Engineering Jobs in None, MA

The Quality Director is responsible for leading all aspects of the company’s quality management program, including inspection, testing, quality assurance, and continuous improvement over 3 manufacturing sites. This is a hands-on leadership position that requires both strategic oversight and direct involvement in inspection and problem-solving activities on the production floor. The Quality Director ensures that products consistently meet customer requirements, internal standards, and applicable regulatory and industry certifications.

Key Responsibilities:

· Champion and uphold the company’s values, vision, mission and quality policy in all activities.

· Adhere to and help enforce company policies, procedures, and internal control standards.

· Direct and manage all activities within the Quality Department, including Quality Engineers, Inspectors, and Technicians.

· Establish department goals, KPIs, and quality objectives that align with company strategy.

· Develop, coach, and evaluate team members to ensure competence, engagement, and accountability. Lead by example, maintaining a visible and active presence on the production floor.

· Oversee and participate in first article, in-process, and final inspections to verify compliance with specifications and drawings.

· Interpret engineering drawings and specifications, including GD&T.

· Use precision measurement tools (calipers, micrometers, indicators, CMMs, gauges, etc.) to verify part conformance.

· Develop, maintain, and continuously improve inspection plans, work instructions, and sampling procedures.

· Maintain calibration and control of all inspection equipment.

· Manage and maintain the company’s QMS in compliance with ISO9001:2015, ISO 13485:2016 and AS9100D (and/or industry-specific standards).

· Lead internal and external audits, ensuring audit findings are documented, corrected, and closed on time.

· Oversee documentation control, ensuring policies, procedures, and records are current and accurate.

· Prepare and submit quality reports and performance metrics to senior leadership.

· Lead root cause analysis and corrective/preventive actions (CAPA) for nonconformances and customer issues.

· Collaborate with production, engineering, and supply chain teams to resolve quality issues and prevent recurrence.

· Drive initiatives to reduce scrap, rework, and process variation.

· Utilize Lean, Six Sigma, or other quality tools to identify and implement process improvements.

· Serve as the primary point of contact for customer quality concerns, audits, and certifications.

· Investigate and resolve customer complaints with professionalism and urgency.

· Manage supplier quality performance and assist with incoming inspection or supplier corrective actions as needed.

· Collect, analyze, and report key quality performance indicators (defect rates, rework, scrap, returns, etc.).

· Use data to identify trends, recommend improvements, and support operational decision-making.

Qualifications:

· Bachelor’s degree in Engineering, Quality Management, or related technical discipline; equivalent experience considered.

· Minimum 7 years of progressive quality experience in a manufacturing environment, including at least 3 years in a leadership role.

· Strong hands-on inspection skills and understanding of dimensional measurement tools and techniques.

· Proven ability to read and interpret complex blueprints and apply GD&T principles.

· In-depth knowledge of ISO9001:2015, ISO 13485:2016 and AS9100D and quality management systems.

· Experience with corrective actions, root cause analysis, and continuous improvement methodologies.

· Excellent leadership, communication, and team-building skills.

· Proficiency in Microsoft Office and quality software systems (SPC, CMM, or QMS software).

· Demonstrated ability to interact effectively with customers, suppliers, and all levels of internal personnel.

· Experience in plastics, precision machining, or manufacturing for regulated industries.

· Experience with PPAP, FMEA, control plans and other advanced quality planning tools.

Work Environment:

· Work environment includes manufacturing and warehouse settings with exposure to machinery, moderate noise and variable temperatures.

· Must be able to stand and move between production and office areas frequently.

· Hands-on leadership expected.

· May involve standing for long periods, lifting up to 50 lbs, and working near machinery.

Expected Hours of Work:

· This is a full-time position, typically Monday through Friday. While weekend work is rare, occasional weekend activity may be required based on business needs.

Travel:

· 10%

· Possible international travel

Are you a hands-on Quality leader who thrives in high-accountability environments and believes great culture drives great results? We’re looking for a Site Quality Manager to lead all Quality functions at our North Billerica facility and play a key role in shaping performance, compliance, and team development.

If you’re passionate about building strong teams, driving continuous improvement, and ensuring world-class quality standards — this is your opportunity to make a measurable impact.

As the Site Quality Manager, you will:

• Lead and continuously improve our AS9100 / ISO 9001 Quality Management System
• Oversee MRB, NCMRs, CAPAs, SCARs, RMAs, and root cause investigations
• Direct all inspection activities (In-Process, Pre-Mold, Final) including AS9102 First Article Inspections
• Ensure cable and harness assemblies meet IPC-620, J-STD-001, AS9102, and customer requirements
• Review and approve work order packages, C of Cs, and shipment documentation
• Monitor quality metrics, defect trends, and drive Zero Defect initiatives
• Lead internal audits and support customer and certification audits
• Partner cross-functionally with Production, Engineering, Planning, Procurement, and Corporate Quality
• Develop and mentor the Quality team, building capability and accountability at every level
• Serve as the primary customer liaison for quality-related matters

Technical Expertise:

• Strong working knowledge of AS9100 Rev D and ISO 9001
• Experience with AS9102 First Article Inspection
• Familiarity with IPC-620 and J-STD-001 (Space Addendum a plus)
• Deep experience with NCMR, MRB, CAPA/RCCA, and root cause analysis
• Aerospace or military manufacturing background preferred
• Ability to read and interpret engineering drawings, wire lists, and MIL specs
• Experience in build-to-print cable/harness manufacturing is a plus

Leadership & Impact:

• 5+ years in Quality Assurance/Quality Control within manufacturing
• Prior team leadership experience
• Proven track record leading corrective actions to closure
• Experience conducting internal audits under AS9100
• Strong analytical skills with the ability to turn data into actionable insights
• Clear, professional communication with customers and suppliers

This is a high-visibility leadership role in a fast-paced aerospace manufacturing environment where quality is mission-critical.

Role Overview

The Key Account Manager (KAM) is responsible for managing and expanding Pion’s most

strategic customer relationships within the Boston market. This role is central to the

company’s growth strategy and carries meaningful ownership over revenue performance,

account expansion and long-term customer value.

The KAM operates with a high degree of autonomy and accountability, working in a

performance-driven environment where accurate forecasting, structured account

planning, and disciplined execution are essential. This is not a transactional sales role - it

requires strategic thinking, scientific credibility and operational rigor.

Key Responsibilities

Strategic Account Management

 Own and execute comprehensive account plans aligned to company growth targets

 Build deep, multi-level relationships across R&D, Analytical, CMC and Procurement

 Understand customer workflows, strategic priorities, and long-term pipelines

 Position Pion as a long-term partner through value-based, consultative engagement

 Identify expansion opportunities tied to new applications, enhanced products and

evolving customer needs

Sales Execution & Growth

 Deliver against defined revenue and growth objectives for assigned territory

 Manage complex sales cycles involving capital equipment, consumables and

services

 Maintain disciplined pipeline management, opportunity qualification and

forecasting

 Ensure CRM accuracy and timely updates to support operational planning and

leadership visibility

 Set and manage customer expectations around manufacturing schedules, lead

times and delivery constraints

Operational Excellence & Rigor

 Operate with a high level of structure, accountability and follow-through

 Partner closely with Operations, Manufacturing, Applications, and Service to drive

predictable outcomes

 Proactively identify risks and constraints, escalating appropriately and early

 Contribute to continuous improvement of sales processes, tools, and cadence

Customer Advocacy & Internal Collaboration

 Serve as the primary commercial owner for assigned territory accounts

 Coordinate internal resources to ensure successful installations, adoption and

ongoing value realization

 Act as the voice of the customer, providing actionable feedback to Product and

Leadership teams

 Navigate escalations and competitive pressures with professionalism and clarity

Market & Competitive Insight

 Maintain strong awareness of regional market dynamics, competitors and emerging

technologies

 Represent Pion customer meetings, scientific forums and industry events

 Identify high-growth opportunities within pharma, biotech, CDMOs and academic

institutions in the Boston ecosystem

Qualifications & Experience

Required

 Advanced degree in Chemistry, Pharmaceutical Sciences, Engineering or a related

scientific discipline preferred

 5+ years of experience in life sciences sales

 Demonstrated success managing complex, high-value strategic accounts

 Strong understanding of drug development workflows

 Ability to operate e􀆯ectively in a performance-driven, growth-oriented environment

 Strong organizational skills with a track record of operational discipline and

execution

 Willingness to travel regionally and occasionally nationally

Preferred

 Experience selling analytical instrumentation or pharmaceutical enabling

technologies

 Familiarity with capital equipment sales cycles

 MBA or advanced scientific degree

 Experience working cross-functionally within a global organization

What Success Looks Like

 Measurable contribution to Pion’s strategic growth targets

 Strong penetration and expansion within assigned key accounts

 Accurate forecasting and disciplined account management

 High customer trust and long-term partnership development

 Consistent demonstration of operational excellence and accountability

Why Join Pion

 Be part of a respected scientific company entering an exciting new growth phase

 Work with enhanced technologies that are expanding Pion’s impact in drug

development

 Operate in a role where individual performance directly influences company

success

 Collaborate with a knowledgeable, committed team focused on execution and

results

 Competitive compensation, incentive plan and benefits

About Us:

Boston Micro Fabrication (BMF) is a leading provider of micro-precision 3D printing systems and services. We are at the forefront of advanced manufacturing technology, enabling our clients to create high-precision, complex, and microscale parts and products. Our innovative technology is transforming industries such as electronics, medical, microfluidics, and more.

Job Description:

BMF is seeking a highly motivated and experienced Precision Manufacturing Engineering Lead to join and guide our growing team. In this leadership role, you will oversee and mentor a team of engineers and technicians, driving excellence across our precision additive manufacturing operations and customer applications.

This is a hands-on leadership position where you will not only direct and develop the team but also work directly with BMF’s precision additive manufacturing systems. You’ll be actively engaged in running, maintaining, and optimizing the printers, including those configured for ceramic materials, to ensure process consistency, quality, and efficiency across all production activities.

You will play a key role in advancing our applications expertise, pushing the boundaries of ceramic and polymer 3D printing materials, and ensuring that all production and application development efforts meet the rigorous standards required for a precision manufacturing environment. This position combines hands-on technical execution, materials understanding, strategic leadership, and cross-functional collaboration to ensure consistent, high-quality, and compliant results.

As the Precision Manufacturing Engineering Lead, you will:

• Hands-On Production & Workflow Management: Actively operate, maintain, and optimize BMF’s 3D printer fleet at the Maynard, MA facility—including systems dedicated to ceramic and other advanced materials. Manage daily print operations, production scheduling, and throughput while ensuring quality control, compliance with applicable standards and regulations, and adherence to precision manufacturing practices. Lead by example through hands-on engagement in production activities. Develop and optimize 3D printing parameters and processes to achieve precise, repeatable, and high-quality outcomes across ceramics, polymers, and composite materials.

• Leadership & Best Practices: Lead and supervise the Applications Engineering team, setting priorities, allocating resources, and fostering a culture of technical excellence, accountability, and continuous improvement. Maintain and enforce best practices essential for a precision manufacturing environment, ensuring all processes, documentation, and production protocols uphold the highest standards of accuracy, repeatability, quality, and compliance with industry standards and regulatory requirements beyond ISO frameworks.

• Materials Integration: Design and execute experiments to evaluate and qualify both internally developed and third-party materials—including ceramic resins and specialty formulations—for use on BMF systems. Drive materials innovation and integration to expand the range of applications and performance capabilities.

• Sales Collaboration: Partner closely with the Sales Team to address unique customer challenges, translating technical insights into practical solutions. Communicate directly with customers to ensure alignment, satisfaction, and long-term success.

• Industry Insights: Stay current on industry trends, emerging technologies, and evolving use cases in precision ceramics and additive manufacturing. Leverage this knowledge to guide strategic direction, ensure compliance with evolving regulations, and maintain BMF’s leadership in micro-precision 3D printing.

Qualifications:

• Hands-on experience printing with ceramic materials and an understanding of their behavior, post-processing requirements, and design considerations.
• Broader materials background with knowledge of polymers, composites, and resin chemistries.
• Exceptional attention to detail.
• Strong technical aptitude and problem-solving skills.
• Experience in setting up, maintaining, and optimizing best practices and workflows in a precision manufacturing environment.
• Proficiency with production planning, quality control methods, and data analysis.
• Excellent communication and interpersonal skills.
• Experience with additive manufacturing (SLA and/or DLP), with a focus on customer and internal applications and materials qualification.
• Understanding of and ability to ensure compliance with quality, safety, and regulatory standards—including but not limited to ISO 9001, ISO 13485, and other applicable industry and customer-specific regulations.
• Demonstrated success in optimizing print parameters for resin and ceramic materials to achieve desired properties for functional end-use parts.
• Proven ability to manage multiple projects simultaneously while maintaining a high level of accuracy and consistency.
• Ability to work independently and as a team leader.
• Proficiency with CAD tools.

Benefits:

• Competitive salary
• Health, dental, and vision insurance
• Retirement savings plan with Company match
• Professional development opportunities
• Collaborative and innovative work environment

At Boston Micro Fabrication, we value diversity and inclusivity. We encourage individuals from all backgrounds and experiences to apply. If you are passionate about cutting-edge technology, excited to work with leading-edge 3D printing systems, and eager to support our customers in achieving their goals, we invite you to apply to join our team.

Sales Design Engineer – CEA (Controlled Environment Agriculture)

Role Overview

The Sales Design Engineer for CEA plays a critical role at the intersection of sales, engineering, and customer solutions. This position supports the sales process by translating customer needs into technically sound, well-designed CEA systems, while helping ensure feasibility, accuracy, and alignment between sales commitments and execution.

This role partners closely with Sales, Engineering, and Operations to develop conceptual designs, validate system requirements, and support proposals for CEA projects.

Key Responsibilities

• Support the sales team by developing conceptual and preliminary CEA system designs based on customer requirements
• Translate customer goals into technical layouts, system concepts, and solution narratives
• Assist with technical scoping, system feasibility, and early-stage design considerations during the sales process
• Collaborate with internal teams to ensure designs align with engineering standards, cost assumptions, and operational capabilities
• Provide technical input for proposals, presentations, and sales documentation
• Participate in customer discussions as a technical resource when appropriate
• Identify risks, constraints, or design considerations early in the sales cycle to support accurate selling

Training & Development

This role will receive hands-on training and mentorship from senior leadership and subject-matter experts within the organization. The individual will learn directly from seasoned leaders with deep technical and operational expertise, providing a unique opportunity to be trained by the best of the best during onboarding, our President!

Qualifications (Initial)

• Bachelor’s degree in engineering required
• Background in engineering, design, or a technical discipline (or equivalent practical experience)
• Experience with CEA systems, greenhouse design, or related agricultural or industrial systems required
• AutoCAD or Visio experience
• Knowledge of Project Management processes
• Ability to communicate technical concepts clearly to non-technical audiences
• Strong collaboration skills and comfort working cross-functionally
• Detail-oriented, with the ability to think both conceptually and systemically

Success in This Role Looks Like

• Sales opportunities are supported with clear, credible technical designs
• Fewer disconnects between what is sold and what is built
• Strong collaboration and trust between Sales, Engineering, and Operations
• Customers feel confident in the technical solution being proposed

Manufacturing Engineer – Process Planning

Compensation: up to $115,000

Reports to: Manufacturing Engineering Manager

Role Overview

The Manufacturing Engineer supports the development and optimization of manufacturing processes for high‑precision products. This role is central to improving efficiency, enhancing product quality, and ensuring production targets are consistently met. The engineer collaborates across departments—including Design Engineering, Quality, Operations, and the shop floor—to strengthen product flow, maintain documentation accuracy, and drive continuous improvement.

Key Responsibilities

Process & Design Review

• Evaluate product designs for manufacturability, appropriate tolerances, quality requirements, and cost‑impacting features.
• Define the complete manufacturing process for components and assemblies, ensuring alignment with production capabilities.
• Determine fixture and gage requirements for new parts and either design or source the necessary tooling.

Documentation & Systems

• Create and maintain manufacturing routes and bills of material within the ERP system.
• Review Engineering Change Orders and update process documentation accordingly.
• Maintain accurate and up‑to‑date process instructions, tooling documentation, and related technical records.

Collaboration & Problem Solving

• Work closely with manufacturing engineers, design engineers, quality personnel, supervisors, and machine operators to maximize productivity and product quality.
• Participate in root‑cause investigations and corrective actions for quality issues.
• Support continuous improvement initiatives that enhance throughput, reduce waste, and improve consistency.

Required Skills & Competencies

• Experience with CNC machining, including work‑holding principles and machining fundamentals.
• Strong understanding of general machine shop practices and measurement techniques.
• Proficiency with CAD/solid modeling tools and familiarity with engineering drawings, GD&T, and dimensioning standards.
• Experience with ERP/MRP systems for routing, BOM creation, and documentation control.
• Strong computer skills, including Microsoft Office applications.
• Ability to work independently, think creatively, and manage tasks with minimal supervision.
• Effective verbal and written communication skills.

Additional Notes

This role requires a blend of technical expertise, hands‑on problem solving, and cross‑functional collaboration. The ideal candidate is detail‑oriented, proactive, and comfortable working in a fast‑paced manufacturing environment.

Quality Manager – Direct Hire | 1st Shift

Chelmsford, MA

1st Shift

Direct Hire

About the Role

We are seeking an experienced Quality Manager to lead all Quality operations within a growing aerospace/advanced manufacturing environment. This role oversees quality systems, compliance, audits, supplier management, documentation, and continuous improvement initiatives. The ideal candidate brings strong leadership, deep understanding of AS9100, and the ability to drive a high‑performing quality culture.

Responsibilities

• Lead and develop the Quality team through coaching, training, performance reviews, and career planning.
• Manage and maintain all aspects of the Quality Management System (QMS), including AS9100 compliance, audits, and procedure updates.
• Oversee monthly/annual metrics, documentation control, ECO processing, and risk & opportunity tracking.
• Manage CAPA processes (customer, supplier, internal), NMR/MRB workflows, and GIDEP alerts.
• Serve as the primary quality interface for customers and suppliers, supporting reviews, issue resolution, and status updates.
• Support RFQ and Contract Review processes by validating requirements, flow‑downs, QA codes, and risk entries.
• Oversee supplier approvals, certification tracking, site visits, and quarterly supplier ratings.
• Manage calibration systems, PM documentation, government property equipment logs, and inspection activities (incoming, in‑process, final).
• Support NIST/CMMC compliance with IT and complete actions related to infrastructure and cybersecurity.
• Conduct new‑hire onboarding and coordinate training with HR and Manufacturing leadership.
• Maintain compliance with NAVSUP GFP requirements and conduct monthly walk‑around assessments.
• Drive continuous improvement across all quality processes and cross‑functional operations.

Minimum Requirements

• Bachelor’s degree in Business, Engineering, or related field
• 10+ years of relevant experience
• Strong written and verbal communication skills
• Analytical problem‑solving skills
• Background in Total Quality Management and process improvement
• IPC certifications a plus
• Ability to travel to customer sites as needed
• Attention to detail and strong organizational ability
• Experience in printed circuit boards or related manufacturing preferred

Our client, a fast-paced leader in product development, is seeking a Manufacturing/Process Engineer to join their very busy team. The Manufacturing/Process Engineer will support the transition of products from engineering to manufacturing and will be responsible for bringing new products from Design Verification build to Pilot Production. Additionally, the Manufacturing/Process Engineer will support the design, installation, and operation of production processes, including sheet metal fabrication, foaming of refrigeration enclosures, heat pipe assembly, electro-mechanical assembly, and performance testing. They will also collaborate with engineers in Design for Manufacturability to transition new products from Design Verification builds into Manufacturing Validation builds and Mass Production, as well as work in a multidisciplinary production and development team.

To be successful in this role, candidates will utilize SolidWorks to produce deliverables, including production assembly procedures, and will also provide technical training to the production staff for all new product introductions to enhance product quality and maximize production efficiency. In this very important role, candidates must be experienced engineers who can work independently and communicate clearly with managers, co-workers, and clients. Candidates with an Engineering degree in Mechanical, Manufacturing, or Industrial Engineering, and at least 10 years of manufacturing engineering experience, will be considered. Please apply if you meet these qualifications and are local to the Greater Boston area.

Additional Responsibilities and Qualifications

• Troubleshoot and resolve production line failures and technical issues.
• Design and implement functional fixtures and gauges to increase efficiency, improve quality, and minimize defects.
• Support the installation, programming, and maintenance of production equipment and materials.
• Lead continuous improvement initiatives for production line defects and field failures.
• Support the implementation of an ERP system and process ERP data to reinforce a lean manufacturing environment.
• Analyze production times, shop layout, and costs to provide reports for operational decisions.
• Collaborate with engineers to improve control processes for existing products and implement new control processes for new product introductions.
• Experience with refrigeration systems and foaming tools is preferred.
• Experience with various fabrication processes such as vacuum forming, injection molding, sheet metal forming, and rapid prototyping methods
• Working knowledge of Lean Manufacturing and Six Sigma principles is preferred.
• Ability to generate robust mechanical drawings, assembly procedures, and written reports. 3D CAD experience is a must. SolidWorks proficiency required.
• High level of personal commitment to quality, with demonstrated thoroughness and attention to detail in all phases of a process or project.
• Excellent communication and interpersonal skills, highlighted by a flexible and collaborative working style.
• Due to the nature of the work, citizenship or legal residents only will be considered.

Professional Experience

Senior Manufacturing Support Engineer

Pharmaceutical Manufacturing Operations

Billerica, MA

Manufacturing Equipment Support

• Provide advanced troubleshooting and rapid recovery support for pharmaceutical manufacturing equipment to minimize downtime and maintain production schedules.
• Serve as Subject Matter Expert (SME) for critical equipment including isolators, vial filling lines, lyophilizers, sterilizers, washers, and packaging systems.
• Monitor process operations to ensure compliance with manufacturing specifications and cGMP regulations.

Process Equipment Reliability

• Maintain operational readiness of sterile filling and process equipment supporting continuous manufacturing operations.
• Troubleshoot complex issues involving mechanical, electrical, automation, and process systems.
• Operate production equipment for setup, testing, or manufacturing support as required.

Validation & Compliance Support

• Support validation maintenance programs and equipment re-qualification activities.
• Assist Validation Engineers during FAT, SAT, IQ, OQ, and PQ activities for new or modified equipment.
• Maintain equipment documentation and records to support validated manufacturing operations.

Quality & Regulatory Support

• Support change control, deviations, and CAPA investigations within TrackWise or similar systems.
• Ensure compliance with FDA regulations and current Good Manufacturing Practices (cGMP).
• Assist with maintenance SOP improvements and documentation updates.

Engineering & Process Support

• Support Manufacturing Engineers with retrofit, improvement, and upgrade projects for manufacturing and critical systems.
• Provide mentorship and technical support to peers within engineering and maintenance teams.

Operational Support

• Participate in 24/7 on-call support for critical manufacturing equipment.
• Perform non-routine and off-hours troubleshooting activities when required.
• Ensure safe work practices and adherence to company safety policies.

Technical Skills

Systems & Software

• CMMS Systems
• TrackWise
• MasterControl
• LMS
• Building Automation Systems
• Microsoft Office Suite

Technical Skills

• Mechanical Systems
• Electrical Systems
• Automation Systems
• Equipment Maintenance
• Process Equipment Troubleshooting
• Engineering Drawings & Schematics

Education

Bachelor of Science – Mechanical Engineering (Preferred)

or equivalent engineering experience

Associate Degree – STEM Field (Optional)

High School Diploma or Equivalent

Certifications & Training

• cGMP Training
• HAZMAT Training
• State Boiler License (Preferred / Obtain within 6 months)
• Electrician License (Preferred)
• Technical Certifications (Preferred)

Additional Qualifications

• Knowledge of aseptic manufacturing techniques
• Experience in pharmaceutical plant operations and maintenance environments
• Ability to read and create engineering drawings and schematics
• Proficient in hand tools, power equipment, and production machinery
• Valid Driver’s License

Physical & Work Environment

• Ability to lift up to 70 lbs
• Work in manufacturing, laboratory, and warehouse environments
• Exposure to noise, temperature variations, and controlled radiation levels
• Use of PPE including safety shoes, glasses, and gloves

Manufacturing Engineer | Wilmington, MA

Contract-To-Hire (6-Months)

Provide engineering and project management skills in support of the design and development of new processes/equipment, the scale-up and commercialization of new products, the continual improvement of existing technologies, and the optimal performance and troubleshooting of existing operations.

Responsibilities

• Provide strong engineering skills in support of the scale-up and development of new products and processes. This includes methods, procedures and specifications to ensure a timely transfer to Manufacturing.
• Provide strong engineering understanding on continual improvement teams, developing process methods, designing/sourcing equipment, conducting feasibility/developmental trials, executing validation requirements, drafting documents/specifications/drawings, and providing on-the-job training to ensure the effective transfer/start-up of new/refined products/processes.
• Manage equipment and process validations, including creation of the protocol, identification of test requirements, analysis and presentation of results, and creation of the final report, in accordance with internal procedures and external regulations.
• Utilize Lean Manufacturing principles and appropriate tools to drive continual improvement of key operational measures, e.g. yield, velocity, takt time, inventory, nonconformances, etc.
• Provide engineering support to manufacturing and QA groups to ensure that production requirements are satisfied.
• Prepare presentations and reports, as appropriate, to communicate status of engineering projects, progress towards goals and objectives, future opportunities, and current risks/alternatives to senior management.
• Support the site in developing, training, and maintaining calibration/preventative maintenance programs and manufacturing process controls.

Requirements

• 2+ years of experience in an engineering position within a medical device manufacturing organization or GMP/FDA Regulated Environment
• Working knowledge of Lean Manufacturing Principles
• Six Sigma Green Belt Certification a plus.
• Electro-mechanical systems experience is a plus