Mks Instruments Inc Jobs in Usa
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This is a six month assignment in Vacaville
This potsition is for local candidates as there is no travel and living expenses
This is a W2 Position.
Process Engineer I
Summary:
This position is located at Lonza’s production facility in Vacaville, California. The production facility makes pharmaceutical proteins from mammalian cells using large-scale production techniques. This temporary contract position provides hands-on technical support for Process Analytical Technology (PAT) systems deployed on the manufacturing floor at a large-scale biopharmaceutical facility. PAT systems play a critical role in monitoring mammalian cell culture processes by measuring key parameters such as cell density, viability, and metabolite concentrations. Maintaining these systems in a reliable, ready-to-use state is essential for ensuring consistent manufacturing performance.
In this role, you will support day-to-day operation, maintenance, and troubleshooting and repair of PAT instruments used in GMP manufacturing. You will work closely with the Frontline Upstream (FLUS) System Owner, Manufacturing, and Instrumentation staff to assess system issues, perform equipment health checks, execute planned improvements, and assist with investigations into unplanned events. This position supports the increased workload associated with the deployment of several new PAT systems in parallel with existing instruments. This position offers the opportunity to gain hands-on experience with advanced PAT used to support mammalian cell culture and purification operations. The FLUS and Instrumentation groups provide technical support for a wide range of analytical instruments used to monitor cell growth, metabolite profiles, and process performance throughout the manufacturing lifecycle.
Job Duties:
Responsibilities/activities may include, but not limited to:
• Performing routine maintenance, calibration checks, and system readiness activities for PAT instruments such as cell counters and metabolic analyzers (e.g., Cedex Bio, Cedex HiRes, Cedex Cobas).
• Supporting manufacturing operations by responding to system-related issues, troubleshooting instrument performance, and documenting observed problems.
• Assisting in the investigation of unplanned equipment events using structured problem-solving tools and contributing to root cause assessments.
• Conducting equipment health monitoring and contributing to reliability improvement activities to increase system uptime.
• Executing planned equipment changes, minor upgrades, and configuration updates under the direction of the PAT System Owner.
• Reviewing and interpreting instrument data to identify basic trends or abnormalities.
• Supporting adherence to data integrity principles and helping maintain data consistency within systems such as Smartline Data Cockpit.
• Collaborating with Manufacturing, FLUS, Automation, QA, and vendors to ensure systems are functioning as intended.
• Assisting with documentation updates, tracking of work activities, and preparing technical summaries as needed.
• Working independently to accomplish assigned tasks while keeping stakeholders informed of progress.
Education and Experience:
• B.S., M.S., or Ph.D in an engineering or analytical/scientific discipline.
• Prior hands-on experience with analytical systems is required.
• Experience using cell counters and metabolite analyzers (Cedex Bio, Cedex HiRes, Cedex Cobas) in GMP Manufacturing or QC Labs preferred.
Knowledge/Skills/Competencies:
• Working knowledge of current Good Manufacturing Practices (cGMPs) as applied to biopharmaceutical manufacturing or similar regulated industries.
• General understanding of biotech analytical methods and laboratory practices.
• Experience troubleshooting analytical instruments and interpreting equipment performance data.
• Flexibility in problem solving and work hours to meet business objectives.
• Familiarity with data management systems; experience with Smartline Data Cockpit is highly desirable.
• Strong interpersonal and communication skills; able to work effectively with operators, engineers, scientists, and external vendors.
• Ability to work independently and manage assigned tasks with limited supervision.
• Demonstrated ability to evaluate technical situations, propose solutions, and execute corrective actions.
• Strong verbal and written communication skills, including documentation, reporting, and stakeholder updates.
• Ability to build productive working relationships with end users and equipment vendors.
• Strategic thinking mindset with the ability to convert system needs into actionable activities.
• Builds productive relationships with partners; focuses on customer needs.
Electro-Mechanical Assembly Technician
San Diego, CA (Onsite)
Direct Hire
This position pays between $65K - $75 K Per Year
JOB DESCRIPTION
- Physically build deliverable sensor systems: assemble mechanical components, solder electronic components, apply coatings to printed circuit boards, install printed circuit boards into sensor housings, precisely cut and strip wiring, mount fasteners, fasten and/or seal electro-mechanical assemblies by applying various bonding and/or sealing agents
- Perform final machining, cutting, or bonding operations on components such as sensor housing, sense elements, fine wires, etc.
- Assemble wiring harnesses and terminate connectors
- Assemble circuit boards, connectors, ribbon cables, jumpers, and other electronic components into custom-built enclosures
- Test sensors and printed circuit boards using a combination of electrical test equipment and LabVIEW-based software scripts
- Participate actively in inventory management and quarterly inventory checks
- Conduct final assembly of sensor systems onto customer driveshafts, including application of sealant, ensuring integrity of the full assembly, and certifying system fitness for homologation
- Participate in failure analyses by dissecting and analyzing hardware returned from the field, conducting diagnostic and validation testing, and comparing with original results.
- Assist in writing and issuing detailed reports outlining findings
Skill Requirements
- At least 2 years of full-time work experience in a related role
- Attention to detail and good craftsmanship, and a strong concern for quality
- Strong electrical and mechanical assembly skills
- Familiarity with wiring harness assembly protocols using AWG 20-gauge harnesses or smaller
- Familiarity with processing adhesives, soldering, and general machine shop skills
- Proficiency with LabVIEW or equivalent software
- Ability to read and interpret mechanical drawings and electrical schematics
- Understanding and knowledge of sensor or instrumentation calibration protocols
- the candidate is expected to already have a hands-on approach and a certain comfort level building and operating devices and instrumentation.
- Educational Requirements An Associate’s degree in fields such as machining, mechanical technology, electronics, automotive technology, or electronics is preferred but not required.
Applicants should apply via The Mice Groups Inc. website ( ) or through this careers site posting.
We are an equal opportunity employer and value diversity at The Mice Groups Inc. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
Pursuant to the San Francisco Fair Chance Ordinance, we will consider for employment qualified applicants with arrest and conviction records.
Pursuant to the Los Angeles Fair Chance Ordinance, we will consider for employment qualified applicants with arrest and conviction records.
The Mice Groups Inc. values your privacy. Please consult our Candidate Privacy Notice, for information about how we collect, use, and disclose personal information of our candidates.
Privacy Policy
One of the basic principles The Mice Groups follows in designing and operating this website is that we ask for only the information we need to provide the service you’ve requested.
The Mice Groups does not currently collect personal identifying information via its website except (i) to the extent that you provide this information in an online job application and (ii) to the extent that your web browser provides personal identifying information.
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The Mice Groups reserves the right to change this policy at any time by posting a new privacy policy at this location. Questions regarding this statement should be directed to
Work Shift
Day (United States of America)
Job Summary:
Under the general supervision of the Supervisors, Manager or Director, performs clinical laboratory testing pursuant to established and approved protocols requiring the exercise of independent judgment and responsibility, maintains equipment and records, performs quality assurance activities related to test performance and may supervise and teach within the laboratory setting. The Med Tech II is fully proficient in their area of expertise, and will serve as
a Generalist in all areas of the General Lab and Blood Bank, or as a Key Operator / Subject Matter Expert in their assigned area.
Accuracy: Maintains acceptable accuracy in-patient, quality assurance, proficiency, and competency testing.
Critical Thinking: Uses clinical/ theoretical knowledge to analyze, investigate, interpret, and report lab data.
Job Knowledge: Maintains current personal training, education and practice of policies and procedures.
Productivity: Practices organizational skills for efficiency of time, materials, cost, and availability of lab data
Communication: Practices information monitoring, investigation, resolution, and hand-off to team members.
Performs other duties as assigned:
Core Responsibilities and Essential Functions:
PERFORMS RESPONSIBILITIES OF A MEDICAL TECHNOLOGIST
* Works independently analyzing blood and body fluids for ordered diagnostic tests in General laboratory, Blood Bank, or Microbiology sections Results all tests using good lab technique and adheres to established procedures.
* Performs all routine testing in hematology, manual hematology, urinalysis, coagulation, processing, chemistry , manual chemistry, blood bank and microbiology as requested
* Performs all lab supplementary tasks for Quality control, chemical safety, logs all required activities to track workload, work in progress, pending logs and amended information.
* Effectively communicates all information to appropriate personnel as required by policy and procedure. Participates in shift to shift hand-off communication
PERFORMS DUTIES OF SUPERVISORS IN THEIR ABSENCE
* Acts as a resource to the Pathologists. Resolves any issues they require.
* Fields problem phone calls and resolves issues. Checks the critical logs.
* Serves as a technical resource to other techs. Trains techs in new procedures.
* Acts as consultants and advisors to the other Supervisors
SPECIAL ASSIGNED DUTIES MAY INCLUDE:
* Performs scheduled Maintenance on a key instrument.
* Maintains up-to-date procedure manuals.
* Makes sure all daily and weekly maintenance is completed for the instrument.
* Maintain reagent logs and logs all new shipment lot numbers in the log.
* Maintains QC reports. Checks L-J charts and monitors closely any shifts.
* Orders all needed supplies for the area. Keep inventory stocked 2 weeks worth.
* Provides training for new employees in the designated section/instrument. Creates documents and regularly completes Performance Improvement Projects.
* Performs linearity studies and correlation studies bi-annually for their key instrument.
* Evaluates new tests and procedures changes
* Performs C.A.P. surveys when assigned, helps to assign surveys to others when needed.
* Maintains CAP and The Joint Commission readiness
BLOOD BANK DUTIES IF REQUIRED
* Participates in a regular bench rotation in the blood bank on evening or night shift as needed.
* Run automated blood bank instrument according to established procedures.
* Performs stat duties as needed.
* Order and supply blood products where needed.
* Complete work assignments for the shift.
Performs other duties as assigned
Complies with all Wellstar Health System policies, standards of work, and code of conduct.
Required Minimum Education:
- Bachelors Medical Technology or Bachelors Health Science or Bachelors General or Masters Other-Preferred
Required Minimum License(s) and Certification(s):
All certifications are required upon hire unless otherwise stated.
- MT(ASCP) - Medical Technologist or MT(AMT) - Medical Technologist or MT(HEW) - Medical Technologist or MT(AAB) - Medical Technologist or MLS(ASCP) - Medical Laboratory Scientist or MLS(AMT) - Medical Laboratory Scientist
Additional License(s) and Certification(s):
Required Minimum Experience:
Minimum 3 years experience as a Medical Laboratory Scientist. Required and
Epic experience Preferred
Required Minimum Skills:
Computer/data entry experience.
Ability to communicate with various members of the healthcare team.
Ability to use EXCEL, Word and have basic computer operational knowledge.
Join us and discover the support to do more meaningful work—and enjoy a more rewarding life. Connect with the most integrated health system in Georgia, and start a future that gives you more.
Location: San Diego, CA
Seniority Level: Research Associate (RA) / Senior Research Associate (Sr. RA)
Employment Type: Full-time
About OliX Pharmaceuticals
OliX Pharmaceuticals is a clinical-stage biotechnology company developing next-generation RNA interference (RNAi) therapeutics. Our proprietary asymmetric siRNA (asiRNA) platform enables precise, durable gene silencing and supports delivery platforms such as GalNAc-asiRNA for liver-targeted therapies and cp-asiRNA for local delivery (skin, eye, lung). Active clinical programs and global partnerships (including Eli Lilly, L’Oréal, and Hansoh Pharmaceutical) provide a strong foundation for discovery and development. By joining OliX, you’ll help shape the next generation of RNA medicines.
Role Summary
We are seeking a hands-on Research Associate / Senior Research Associate to support the synthesis, deprotection, purification, and analysis of chemically modified oligonucleotides that enable OliX’s RNAi pipeline. You will operate and maintain key instrumentation (e.g., HPLC/UHPLC, preparative LC, TFF, UV–Vis), document work in SOPs, batch records, and reports, and collaborate closely with RNAi chemistry, medicinal chemistry, and biology teams to advance discovery and preclinical programs.
Key Responsibilities
- Execute (or Help) solid-phase oligonucleotide synthesis (SPS) and downstream processing (cleavage, deprotection, desalting).
- Purify and polish oligonucleotides using OPC, analytical and preparative HPLC/UHPLC, and UPLC; perform buffer exchange and concentration via TFF.
- Develop and optimize purification methods and in-process controls to improve yield, purity, and throughput.
- Perform analytical characterization (UHPLC/LC–MS, UV–Vis); compile CoAs, batch records, and data summaries.
- Operate, maintain, and troubleshoot lab instruments; coordinate vendor service when needed.
- Author and revise SOPs, work instructions, and technical reports; ensure data integrity and traceability.
- Work cross-functionally with medicinal chemistry and biology teams to align materials specifications and timelines.
- Maintain safe, compliant laboratory operations and good housekeeping (5S); participate in EHS initiatives.
- (Sr. RA) Mentor junior team members; lead small method-development or process-improvement projects.
Qualifications
Required (RA):
- B.S. in Chemistry, Biochemistry, Chemical Engineering, or related field with 0–3+ years of relevant lab experience (industry or academic core facility).
- Hands-on experience with oligonucleotide purification (e.g., OPC, HPLC/UHPLC, preparative HPLC in anion exchange and reverse phase chromatography) and basic analytical techniques (UV–Vis, KF, etc).
- Familiarity with solid-phase synthesis of workflows and routine instrument maintenance.
- Strong record-keeping and communication; proven ability to meet deadlines and work effectively in a team.
Required (Sr. RA):
- B.S./M.S. in a related field with 3–6+ years of relevant industry experience in oligonucleotide synthesis/purification.
- Demonstrated proficiency in method development/optimization for oligo purification and in-process analytics.
- Experience drafting SOPs/batch records and mentoring junior staff.
Preferred (both levels):
- Experience with LC–MS data acquisition/interpretation for oligonucleotides.
- Exposure to nucleoside/nucleotide building blocks or bioconjugation workflows supporting RNAi platforms.
- Familiarity with TFF operations and scale-up considerations.
Why Join OliX
- Contribute directly to an innovative RNAi pipeline with active clinical programs and world-class partnerships.
- Collaborative, growth-focused environment with cross-functional exposure.
- Competitive compensation and benefits package (medical, dental, vision, 401(k), equity eligibility, paid holidays/year-end shutdown, stock options).
- Base salary range of $60,000 – $90,000 (depending on experience and qualifications)
Work Environment
- Onsite laboratory role with routine handling of chemicals and analytical instrumentation.
- Some lifting (up to ~50 lb) and extended periods at the bench or operating instrumentation.
- Occasional off-hours support during critical runs.
OliX Pharmaceuticals is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
In this role you will serve as an advanced technician supporting the Global Instruments Quality organization.
RESPONSIBILITIES : Perform advanced troubleshooting, repairs, and final acceptance testing on medical devices, including cleaning, decontaminating, disassembly, and final assembly, while adhering to Electrostatic Discharge (ESD) and safety procedures.
Resolve complex problems by gathering, analyzing, and interpreting data with high accuracy and insight.
Demonstrate financial responsibility by independently approving repairs up to $2,000.
Make cost-effective decisions to ensure efficient and budget-conscious repairs.
Provide advanced support to other technicians and lead technical training sessions.
Work autonomously with minimal supervision, effectively managing tasks and making informed decisions independently.
Assist Lead Technicians with advanced repairs.
Handle and maneuver small components and parts.
Analyze calibration and service data to verify compliance with acceptance criteria.
Oversee the processing, review, and routing of Purchase/Work Orders for approval, ensuring efficiency and accuracy.
Complete detailed test records and work orders according to procedures with high accuracy and timeliness.
Lead routine cleaning, decontamination, and surveillance testing of lab space in accordance with Standard Operating Procedures (SOPs).
Inspect equipment, standards, parts, and mechanical components for errors, flaws, and certification/calibration status prior to use, and recommend improvements.
Ensure strict compliance with industry standards and best manufacturing and documentation practices.
Complete assigned training curriculum prior to due dates to avoid late training instances.
Troubleshoot and resolve complex technical problems from the product line/process to minimize reject levels and increase throughput.
Maintain accurate records, support the management of spare parts inventory and materials, and provide team members with necessary information to procure replacement parts or special materials required for effective equipment repairs.
BASIC QUALIFICATIONS | EDUCATION: 2-year degree, or equivalent combination of experience and education.
4+ years of diverse experience in high volume production setting adhering to ISO and FDA Regulations Experience operating in an organization adhering to ISO, FDA, or comparable quality systems and regulations.
Ability to read and understand mechanical, electrical and optical diagrams and technical specifications Hands-on electro-mechanical repair, rebuild, field service experience.
Experience with instrumentation in the medical field.
Preferred Qualifications 4+ years’ experience as an electromechanical technician, experience with instrumentation in the medical field.
COMPETENCIES: Skill in using computer applications including spreadsheet, database, and word processing software.
Demonstrates knowledge of applicable safety/quality standard and practices required in the manufacture of Abbott products through personal work habits.
Ability to clearly communicate ideas, problems and solutions to engineers.
Assist in support of electro-mechanical assembly Rebuild mechanical equipment to perform mechanical trouble Diagnose complex mechanical/electrical systems Performing electrical and mechanical maintenance on all equipment Use a variety of mechanical and electrical test equipment Reassembled electro-mechanical equipment for proper output and operation Fabricate, assemble, and test electro-mechanical fixtures Assemble and test electro-mechanical flight systems in a lab environment Correct mechanical and basic electrical problems Verify electrical and mechanical system operation Utilizing electrical/electronic and mechanical skills Defining and documenting maintenance requirements for electro-mechanical fixtures and equipment Build electro-mechanical circuits, wire and program PLC Perform electrical and mechanical maintenance on all equipment and machinery Modify and repair electrical and mechanical equipment and related controls Perform electro-mechanical testing with minimal supervision from engineers or managers Develop and manage electrical and mechanical solutions Interpret mechanical and electrical drawings and schematics Operate equipment within operational capabilities and limitations of electrical/mechanical systems Supporting performance testing, validation testing of electro-mechanical, pneumatic and hydraulic components and systems
The Manager of Quality Assurance is responsible for overseeing the Quality Department to ensure compliance with ISO 9001 standards and company quality objectives. This role manages quality staff, supports manufacturing operations, and drives continuous improvement initiatives. Key responsibilities include maintaining quality systems, leading audits, supporting new product introductions, managing corrective actions, and monitoring supplier performance. The Manager of Quality Assurance also develops training and reports on quality metrics, and manages departmental resources to improve product quality, customer satisfaction, and overall business performance. This is a working manager role requiring the incumbent to both lead the quality function and directly perform hands-on quality engineering and assurance activities as the business needs dictate.
PRINCIPAL DUTIES AND RESPONSIBILITIES (ESSENTIAL FUNCTIONS)
- Manage the quality department, directing the work of quality technicians to satisfy the quality requirements for the current business and future business improvement.
- Develop and execute annual quality goals and objectives that align with overall company goals and long-range strategy plans.
- Assure that the Quality System is active and the ISO 9001 registration is maintained with minimal audit findings. This includes the many aspects including management reviews, internal audits, risk assessment and those outlined below.
- Provide technical support to manufacturing through the Quality Team.
- Participate in any new product introduction or product change projects, assuring that all requisite quality characteristics and requirements are met.
- Maintain accurate calibration of all measuring instruments and any tools that require such calibration.
- Actively direct the corrective action system for customer complaints/returns, internal processes as well as purchased product and material.
- Work with Mfg. Engineering and Maintenance; develop and guide documented evidence of machine and process capability.
- Develop training and education for the business in key aspects of quality, including the quality department and new hires.
- Lead Receiving Inspection and assist in driving the Supplier Quality Program to improve overall Supplier performance.
- Provide management with measurements of our product, process and customer/supplier quality and recommendations for both remedial as well as preventive measures to be taken with alternatives, costs, resources, timing and risk and benefit analysis.
- As part of business planning, lead the development of quality plans and improvement plans that have a positive impact on the overall cost of quality.
- Manage resources, including budgets, expense recommendations and capital appropriations to ensure effectiveness of the quality system and improve overall gross margins.
EDUCATION AND EXPERIENCE
- A bachelor's degree in quality or an engineering discipline.
- 10 years of pertinent experience in a manufacturing-based business.
KNOWLEDGE, SKILLS AND ABILITIES
- Knowledge of quality methods, tools and instruments.
- Strong background with ISO 9000 quality system requirements.
- Strong problem solving skills.
- Ability to develop and implement training for part measurement/inspection, quality systems and TQM methods.
- Excellent communication skills.
- Computer skills including Microsoft Word, Excel, Power Point at a minimum.
- General knowledge of safety and environmental requirements in a manufacturing environment.
PHYSICAL DEMANDS
- Physical demands are typical of an office position including extended periods of sitting, extensive use of a personal computer and telephone.
- Position requires movement around the facilities.
- Occasional handling of material and components
WORKING CONDITIONS
Normal manufacturing and office environment. When working occasionally in some shop areas, personal protection equipment (PPE) will be recommended and/or required (safety shoes, safety glasses w/side shields, hearing protection, face shield, gloves, apron and boots). Must have the ability to support extended business hours to meet customer business needs.
DISCLAIMER
The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of personnel so classified.
QUALITY
Quality encompasses all aspects of DeZURIK, Inc.'s business, and every team member shares the responsibility to prevent the occurrence of any nonconformity relating to product, process, and the quality system. All team members have an obligation to identify and record any such nonconformity, and, through designated channels, initiate and recommend solutions.
SALARY AND BENEFITS
DeZURIK offers a competitive base salary in the $98,221 to $122,776 range, based on experience and qualifications, along with annual bonus opportunities tied to performance.
Beyond pay, our market-leading benefits are designed to support your wellbeing. These include medical, dental, vision, and life insurance, as well as short- and long-term disability coverage. DeZURIK also provides a health savings account with company match, a retirement plan for employer contributions through Vanguard, and access to the Granite Assistance Fund for support when it's needed most. We value time for rest and personal growth, offering generous paid time off, including volunteer time off and paid holidays.
Please note: Sponsorship is not available for this role.
#LI-JW1
Job Description
Job Title: Tool Maker
Location: Troy, AL
Classification: Non-Exempt
Grade: Hourly
Department: CNC
Reports To : Manufacturing Engineering Manager
Date: August 27, 2025
Summary/Objective
This position requires a highly motivated individual with extensive experience working in a Tool Room environment. The role demands strong knowledge of manual machining techniques (turning, grinding, milling) as well as CNC machines with MDI and Fanuc controls, including the ability to write programs when required. Candidates must demonstrate a solid background in fixture and gage building, at least 5 years of fixture design/repair experience, and the ability to contribute constructive input during fixture/tooling design reviews. Proficiency in reading blueprints and GD&T is essential.
Essential Duties & Responsibilities
- Under limited supervision, fabricate, repair, and improve tools, jigs, fixtures, simple molds, gauges, and dies to the tolerances required for manufacturing processes.
- Work from engineering drawings, sketches, prototypes, and design documents to manufacture dies, fixtures, jigs, and tooling, applying knowledge of materials, machining methods, assembly processes, and mathematics.
- Maintain tooling, fixtures, materials, and CNC programs in an organized and systematic manner to ensure proper process execution.
- Machine precision components by measuring, marking, and scribing stock; setting up and operating lathes, mills, drills, grinders, EDM, and CNC equipment when required.
- Inspect and verify component accuracy using micrometers, calipers, dial indicators, gauge blocks, and other precision instruments.
- Assemble and fit dies by shaping, smoothing, and aligning components; secure assemblies with bolts, dowels, and fasteners; connect wiring or hydraulic lines as required.
- Reverse-engineer existing dies, fixtures, and tooling components to reproduce, modify, or improve designs where documentation is limited or unavailable.
- Provide feedback and suggestions on design improvements to enhance manufacturability, performance, and durability.
- Manage multiple tooling projects simultaneously, prioritizing tasks to meet production and quality requirements.
- Perform preventive maintenance on tools and machines; follow manufacturer guidelines; coordinate repairs to minimize downtime.
- Maintain adequate supply levels by monitoring usage, forecasting needs, and coordinating material orders.
- Document tooling changes, repairs, and maintenance records to support workflow continuity.
- Participate in continuous improvement initiatives to reduce waste, improve efficiency, and support lean manufacturing practices.
- Train and mentor apprentices or junior machinists in safe toolmaking practices and precision machining skills.
- Ensure work areas are organized, clean, and hazard-free; promote 5S practices.
- Perform other duties as assigned.
Minimum Requirements:
- Proficient with mechanical inspection tools, controls, and instrumentation
- Manufacturing and machining experience (manual and CNC)
- Ability to read and interpret blueprints and technical drawings, including GD&T
- Experience maintaining and changing tools
- Strong problem-solving and decision-making abilities
- Excellent documentation and reporting skills
- Effective teamwork and communication abilities
- Hands-on experience in tool and die build, fitting, and maintenance
- Expertise in reverse engineering methods for dies, fixtures, and tooling
- Experience with CAD/CAM software
- CNC machining experience, including G-code programming and troubleshooting
- Experience determining CNC offsets and making adjustments
- Ability to interpret work orders and enter data into a manufacturing database (ERP)
- Familiarity with GD&T standards
- Lean manufacturing and 5S knowledge
Required:
- High School Diploma, GED, or equivalent experience
- Previous Tool Room experience
- Vocational/Technical degree in machining, toolmaking, or related field
- 5+ years of CNC machining experience
- 5+ years of Tool Room experience
- 5+ years of manual machining experience
- Lean manufacturing experience
Attendance is an essential job requirement defined as having regular, consistent, reliable, punctual and predictable attendance including the ability to work regular hours and shifts, overtime before and after shifts and on weekends. Ability to work as part of a team, including all related departments/plants or independently as required to achieve internal and external customer satisfaction.
WORK ENVIRONMENT
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The noise level in the work environment is usually moderate.
While performing the duties of the job the employee works in a manufacturing environment and may be exposed to fumes or airborne particles, moving mechanical parts and vibration.
Physical Requirements
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job the employee is regularly required to talk or hear. The employee is frequently required to sit and use hands to touch, handle, or feel. The employee is occasionally required to stand, walk, reach with hands and arms, climb or balance and stoop, kneel, or crouch.
The employee is occasionally required to lift up to 50 pounds. The vision requirements include close vision and ability to adjust focus.
WORK AUTHORIZATION
This position requires compliance with the Export Administration Regulations (“EAR”). Must be a “U.S. Person” as defined by all pertinent regulations and are required to show proof substantiating this upon being hired.
Other Duties
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Activities, duties and/or responsibilities may change at any time with or without notice at the sole discretion of the Company.
Purpose:
Steel America is seeking 2nd Class Inside Machinists experienced in Manual Machining and/or CNC Mills & Lathes to support operations in the Inside Machine Shop in Norfolk, VA.
Job Description:
- Examines blueprints, sketches, drawings, manuals, specifications, or sample parts to determine dimensions and tolerances of finished work piece, sequence of operations, and setup requirements.
- Perform complex operations on various machine tools, including drill presses, lathes, milling machines, boring machines, and precision grinding machines.
- Measure, mark, and scribe dimensions and reference points on material or work piece as guides for subsequent machining.
- Read precision instruments such as micrometers, calipers, and indicators.
- Select, align, and secure holding fixtures, cutting tools, attachments, accessories, and materials on machines such as mills, lathes, jig borers, grinders, and shapers.
- Select standard materials required for fabrication and machining work.
- Perform the machining operations, watch for problems in the production process, and check the accuracy of the finished piece against blueprints / verify conformance of finished work piece to specifications.
- Observe equipment to detect malfunctions or out-of-tolerance machining, adjust equipment controls as necessary, and verify accuracy of machine settings or programmed control data.
- Set up and operate all types of shop machining tools or equipment to manufacture various parts.
- Verifies dimensions and alignment of assembly, assembles parts into complete assembly.
- Install machined replacement parts in mechanisms, machines, and equipment, and tests operation of unit to ensure functionality and performance.
- Develops specifications from general description and draws sketch of part or product to be fabricated.
- Confers with engineers, production personnel, programmers, or others to resolve machining or assembly problems.
- Work includes small and large assembly, and machining of heavy steel.
- Apply knowledge of mechanics, shop mathematics, machinability of materials, and machine shop procedures
- Perform machine maintenance and is responsible for keeping work are clean and the immediate reporting of safety issues to Supervisor.
- Use various hand and power tools for the completion of job tasks.
- Work independently to complete responsibilities.
- Other duties as assigned.
Qualifications:
- Must have ability to read and interpret blueprints, drawings, and other technical trade related documents.
- Must have at least five (5) years of experience operating manual OR CNC lathes and milling machines.
- Must have Manual Machinist experience as follows:
- Under minimal supervision, a manual machinist sets up and operates manually controlled machines in skilled precision and bench work in the fabrication, maintenance, repair, and alteration of machinery, machine parts, tools, and equipment.
- Must have CNC Mills & Lathes experience as follows:
- Requires knowledge of some CNC programming with the ability to perform minor program edits on the shop floor. Requires more than CNC operation experience.
- Must have mechanical ability, manual dexterity, and hand/eye coordination required to perform various projects, per drawings, sketches, and verbal or written instructions.
- Must be familiar with the use of precision measuring instruments: outside/inside micrometers, depth mics, venires, etc.
- Must be able to write comprehensive Condition Found Reports (CFR) describing the material condition of the parts and assemblies being worked and recommendations for repair.
- Must be familiar with threading and the various measuring/gauging requirements.
- Must be skilled in the selection, set-up, and operation of the appropriate tool(s) for a given type of work.
- Must be able to work effectively with others.
- Must be a steady, reliable worker.
- Must be able to perform duties with minimal supervision.
- Must have own tools.
- Must have regular, reliable attendance.
Preferred Qualifications:
- Forklift and overhead crane experience preferred.
- Knowledge of CNC programming preferred.
Travel Requirements:
- Minimal Travel; 10% or less.
Physical Requirements:
- Must be able to lift, carry and transport heavy equipment and boxes. The exact weight requirements will be determined by the specific job, but no less than 20 lbs.
- Able to work on and climb ladders, work in extreme temperature environments, aboard ships, in shipyards, under industrial conditions and in confined spaces, including enter and moving through manholes.
- Able to perform other duties as required which may involve high heat, humidity, noise and dirty conditions.
- Frequent exposure to noise due to machinery and equipment.
- Employee is required to operate trucks, forklifts & man-lifts.
- While performing the duties of this job, you may frequently be required to stand, walk & sit; use hands or fingers; handle or feel; talk and hear. Occasionally required to reach with hands and arms, climb and balance, stoop, squat, kneel, twist and crawl.
- Work in extreme temperatures and conditions. At times you will work in areas that have less adequate ventilation
- Frequent use of respirator.
Respect, Pride, Truth, Family - These are our VALUES and the guidelines that make us a leader in our industry. We are pleased and confident in stating that our skilled employees are among the most respected experts in the ship repair industry.
Colonna's Shipyard Inc., and its divisions, are committed to ensuring equal employment opportunities for all job applicants and employees. Employment decisions are based upon job-related reasons regardless of an applicant's race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, marital status, genetic information, protected veteran status, or any other status protected by law.
Additionally, Colonna's Shipyard provides a variety of benefits to support your best health, wellness, and future, to include medical/dental/vision options, company paid disability insurances, 401k with match, legal services, as well as company paid holidays and paid time off (PTO).
POSITION SUMMARY:
The Senior Director / Vice President of Manufacturing is a senior leadership role primarily responsible for overseeing, optimizing, and scaling all manufacturing-related functions. This role has a strong hands-on focus on manufacturing execution, production planning, sustaining engineering, and supply chain readiness within a regulated medical device environment.
The position ensures manufacturing excellence across quality, cost, delivery, and compliance, while partnering with R&D and Quality to support product development, transfer, and commercialization. Success is defined by building scalable manufacturing processes, improving efficiency, and ensuring consistent, compliant production to support business growth.
RESPONSIBILITIES:
- Provide executive leadership and direct oversight of all manufacturing operations, including production, assembly, kitting, purchasing, supplier management, and sustaining engineering.
- Develop and execute a manufacturing strategy aligned with company growth, product roadmap, and commercialization timelines.
- Own manufacturing readiness for new product introductions (NPI), including design transfer, process validation, equipment qualification, and scale-up.
- Drive manufacturing efficiency, yield, cost reduction, and capacity planning through Lean manufacturing, Six Sigma, and continuous improvement initiatives.
- Establish and maintain best practices for production planning, inventory management, component sourcing, and supplier performance.
- Oversee sustaining engineering activities, including manufacturing engineering, equipment maintenance and qualification, root cause investigations, and product failure analysis.
- Partner closely with R&D to ensure manufacturability, process robustness, and smooth transition from development to production.
- Collaborate with Quality Assurance to define, implement, and maintain manufacturing and production procedures compliant with FDA, ISO 13485, MDD/MDR, and other applicable international regulations.
- Ensure manufacturing operations consistently meet quality, regulatory, and documentation requirements.
- Lead, mentor, and develop manufacturing managers and staff, fostering accountability, engagement, and a culture of safety, quality, and continuous improvement.
- Establish manufacturing KPIs (e.g., throughput, yield, scrap, on-time delivery, cost) and use data-driven insights to drive performance improvements.
- Manage multiple manufacturing projects and priorities through clear policies, procedures, and systems.
- Serve as the primary manufacturing interface with suppliers, contract manufacturers, auditors, and regulatory agencies, as needed.
OTHER RESPONSIBILITIES:
May require domestic and international (including China) travel.
REQUIRED SKILLS AND EXPERIENCE:
- 12–15+ years of progressive manufacturing leadership experience, preferably within the medical device industry. Final leveling (Senior Director or Vice President) will be determined based on experience, scope, and organizational needs.
- At least 7+ years of progressive responsibility leading manufacturing, production, and sustaining engineering teams in a regulated environment.
- Deep working knowledge of FDA, ISO 13485, MDD/MDR, and international manufacturing and quality requirements.
- Proven experience leading manufacturing scale-up, process validation, and product commercialization.
- Strong background in Lean manufacturing, Six Sigma, and driving measurable improvements in cost, quality, yield, and delivery.
- Demonstrated success in manufacturing transfer from R&D to production and supporting ongoing sustaining activities.
- Experience managing suppliers, component sourcing, and external manufacturing partners.
- Ability to work effectively with cross-functional teams, including R&D, Quality, Regulatory, and Supply Chain, to resolve manufacturing and production challenges.
- Excellent verbal, written, and interpersonal communication skills, with the ability to influence across technical and leadership teams.
- Advanced proficiency in Microsoft Word, Excel, PowerPoint and NetSuite.
EDUCATION:
Bachelor’s degree in Operations, Engineering, Manufacturing, or a related field, or equivalent experience required. Advanced degree desirable.
Annual Base Salary: $200,000 – $290,000 DOE (Depending on Experience)
Location: San Leandro, CA (Onsite, Full-time)
Company Website: Type: Full-time
Medical Instrument Development Laboratories, Inc. (MIDLabs) is an equal opportunity employer. We are committed to fostering an inclusive, diverse, and respectful work environment and do not discriminate based on race, color, religion, sex, national origin, age, disability, sexual orientation, gender identity, or any other legally protected characteristic. Applicants from all backgrounds are encouraged to apply.
Note: This post is for informational purposes only. We are not accepting unsolicited recruiter inquiries at this time.
Hiring for GxP Systems Development Engineer in Norwood, MA
Job Title: GxP Systems Development Engineer
Location: Norwood, MA
Role Overview
The GxP Systems Development Engineer supports the implementation, upgrade, and validation of laboratory informatics systems (e.g., SDMS, LIMS, ELN) in GMP-regulated environments. This role ensures system compliance, data integrity, and seamless integration with laboratory instruments.
Key Responsibilities
- Support implementation and upgrades of LogiLab SDMS, including deployment and instrument integration
- Execute validation activities (IQ/OQ/PQ), test scripts, and traceability documentation
- Collaborate with infrastructure and validation teams for system upgrades and performance
- Perform regression testing and system verification post-upgrade
- Assist with change control and maintain validation/SOP documentation
- Ensure compliance with ALCOA+ data integrity principles
- Support UAT, issue resolution, and system optimization with cross-functional teams
Required Qualifications
- Bachelor’s degree in Life Sciences, Engineering, Computer Science, or related field
- 3–6+ years of experience with lab systems (SDMS, LIMS, ELN, CDS) in GMP environments
- Knowledge of GxP frameworks (GAMP 5, 21 CFR Part 11, Annex 11)
- Experience with system validation (IQ/OQ/PQ) and change control processes
- Hands-on experience with system upgrades or migrations
- Understanding of lab instrument integration and digital workflows
- Strong attention to detail and collaboration skills
