Active And Passive Devices Examples Jobs in Usa

Job Title: Medical Device Packaging Design Engineer

Location: On-site in Huntley, IL

Position Brief:

The Chatham Group Advanced Materials and Technologies Recruiting Team is seeking highly qualified candidates for a Medical Device Packaging Design Engineer for a client in the specialty packaging technology industry. This is a mid-junior level position that requires hands-on experience with rigid thermoformed packaging design concepts with experience in medical device packaging and sterile polymer barrier systems. You will work closely with the manufacturing engineering and quality assurance teams to deliver compliant and production ready packaging solutions for new and existing products.

Responsibilities:

• Design medical device packaging systems from initial concept through testing and production using CAD programs, particularly SolidWorks
• Use CAD programs to develop 3D models and assemblies as well as 2D drawings for specification
• Evaluate various polymeric materials such as PET, HIPS, Polypropylene, etc for their performance properties such as wall thickness, strength, rigidity, sterilization, and more
• Create prototype products using existing tooling or 3D printing technologies and conduct feasibility reviews for functional integrity, stackability, etc
• Lead the IQ/OQ/PQ product validation process and comply with ISO 13485 standards for medical device quality
• Manage ISO 11607-1 and ISO 11607-2 compliance process for medical device packaging sterilization

Requirements:

• BS in Packaging Engineering, Packaging Science, or Mechanical Engineering
• 4-5 years of experience in packaging design with ideally around 2 years of experience in medical device packaging
• High proficiency with CAD programs, particularly SolidWorks
• Working knowledge of thin-gauge thermoformed packing design
• Understanding of medical packaging standards, sterilization techniques, etc
• Experience with clean room manufacturing environments

Compensation will be commensurate with experience and relocation may be provided to qualified candidates.

ESSENTIAL FUNCTIONS:

· Acts as a problem solver as it relates to patient, family, physician issues according to protocol.

· Anticipates need for wearable defibrillators

· Anticipates potential symptomatic consequences of CIED evaluations and programming.

· Communicates with industry sales, clinical support and technical services representatives regarding CIED function, safety and battery longevity.

· Communicates with patient and family members regarding CIED lifesaving therapies including fielding patient’s and family’s questions regarding end-of-life matters related to CIED therapy.

· Facilitates home wellbeing checks by public services and recognizes the potential for discovering patient death on remote CIED follow-up

· Maintains practice standards in regard to Quality Improvement and OSHA.

· Operate required vehicle(s) in a safe manner to perform required duties of the position.

· Performs general and cardiac nursing care to patients. Administers prescribed medications and treatment in accordance with nursing standards.

· Performs in-person interrogation and any needed reprogramming on all cardiac implantable electronic device (CIED) models of pacemakers, ICDs and Implantable Loop Recorders (ILRs) and documents according to IHC protocols.

· Provides assistance to Electrophysiology (EP) provider in office, and facilitates office schedule.

· Provides guidance on peri-procedural, peri-surgical and MRI device management

· Provides patient and family education and documents in medical records.

· Reads and researches patient records, charts and Practice Manager System for other pertinent information. May dictate history and physical, consults and other professional related letters.

· Reviews and reports pertinent test(s) results, outside examination results and patient symptoms; scrutinize for needed follow-up; communicates to provider.

· Reviews CIED remote transmissions and completes documentation according to IHC protocol.

· Triages phone calls and significant device evaluation findings, gives carries out verbal and written orders according to standing orders or established protocols.

MARGINAL FUNCTIONS:

· All other duties as assigned.

· Attends required meetings and participates on committees as required

· Clinical resource for the Heart Rhythm Center’s Arrhythmia services Technicians.

· Monitors and maintains supplies on crash cart.

· Participates in professional development.

MINIMUM KNOWLEDGE, SKILLS AND ABILITIES REQUIRED:

· Three years of RN nursing experience required. Two years of critical care experience preferred or clinical cardiac equivalent experience required.

· Current licensure as R.N., state of Iowa or compact state.

· Valid Iowa Driver’s/Chauffeurs License required, must meet Mercy’s Motor Vehicle Safety Standards, must be at least 18 years of age and be eligible to drive per Iowa state law.

· Proof of completion of Mandatory Reporter abuse training specific to population served within three (3) months of hire.

· Basic Life Support (BLS) for the Healthcare Provider certified or obtained by the end of the orientation period (approximately six (6) weeks). Acceptable credentialing bodies and certifications include American Heart Association Basic Life Support for Healthcare Providers.

· ACLS within 6 months of hire

· Level I Cardiac Arrhythmia class completion within 6 months

· Level II 12 Lead EKG class completion within 1 year

· Level III Advanced 12 Lead EKG class within 18 months

· International Board of Heart Rhythm Examiners (IBHRE) Cardiac Device Remote Monitor Specialist (CDRMS) certification examination following 1 year following device training, prior to the end of the 3rd year of performing CIED in-office evaluations

· IBHRE Certified Cardiac Device Specialist (CCDS) certification encouraged following 3 years of CIED follow-up and successful completion of the CDRMS examination with a passing score

Our Commitment

Rooted in our Mission and Core Values, we honor the dignity of every person and recognize the unique perspectives, experiences, and talents each colleague brings. By finding common ground and embracing our differences, we grow stronger together and deliver more compassionate, person-centered care. We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other status protected by federal, state, or local law.

ESSENTIAL FUNCTIONS:

· Acts as a problem solver as it relates to patient, family, physician issues according to protocol.

· Anticipates need for wearable defibrillators

· Anticipates potential symptomatic consequences of CIED evaluations and programming.

· Communicates with industry sales, clinical support and technical services representatives regarding CIED function, safety and battery longevity.

· Communicates with patient and family members regarding CIED lifesaving therapies including fielding patient’s and family’s questions regarding end-of-life matters related to CIED therapy.

· Facilitates home wellbeing checks by public services and recognizes the potential for discovering patient death on remote CIED follow-up

· Maintains practice standards in regard to Quality Improvement and OSHA.

· Operate required vehicle(s) in a safe manner to perform required duties of the position.

· Performs general and cardiac nursing care to patients. Administers prescribed medications and treatment in accordance with nursing standards.

· Performs in-person interrogation and any needed reprogramming on all cardiac implantable electronic device (CIED) models of pacemakers, ICDs and Implantable Loop Recorders (ILRs) and documents according to IHC protocols.

· Provides assistance to Electrophysiology (EP) provider in office, and facilitates office schedule.

· Provides guidance on peri-procedural, peri-surgical and MRI device management

· Provides patient and family education and documents in medical records.

· Reads and researches patient records, charts and Practice Manager System for other pertinent information. May dictate history and physical, consults and other professional related letters.

· Reviews and reports pertinent test(s) results, outside examination results and patient symptoms; scrutinize for needed follow-up; communicates to provider.

· Reviews CIED remote transmissions and completes documentation according to IHC protocol.

· Triages phone calls and significant device evaluation findings, gives carries out verbal and written orders according to standing orders or established protocols.

MARGINAL FUNCTIONS:

· All other duties as assigned.

· Attends required meetings and participates on committees as required

· Clinical resource for the Heart Rhythm Center’s Arrhythmia services Technicians.

· Monitors and maintains supplies on crash cart.

· Participates in professional development.

MINIMUM KNOWLEDGE, SKILLS AND ABILITIES REQUIRED:

· Three years of RN nursing experience required. Two years of critical care experience preferred or clinical cardiac equivalent experience required.

· Current licensure as R.N., state of Iowa or compact state.

· Valid Iowa Driver’s/Chauffeurs License required, must meet Mercy’s Motor Vehicle Safety Standards, must be at least 18 years of age and be eligible to drive per Iowa state law.

· Proof of completion of Mandatory Reporter abuse training specific to population served within three (3) months of hire.

· Basic Life Support (BLS) for the Healthcare Provider certified or obtained by the end of the orientation period (approximately six (6) weeks). Acceptable credentialing bodies and certifications include American Heart Association Basic Life Support for Healthcare Providers.

· ACLS within 6 months of hire

· Level I Cardiac Arrhythmia class completion within 6 months

· Level II 12 Lead EKG class completion within 1 year

· Level III Advanced 12 Lead EKG class within 18 months

· International Board of Heart Rhythm Examiners (IBHRE) Cardiac Device Remote Monitor Specialist (CDRMS) certification examination following 1 year following device training, prior to the end of the 3rd year of performing CIED in-office evaluations

· IBHRE Certified Cardiac Device Specialist (CCDS) certification encouraged following 3 years of CIED follow-up and successful completion of the CDRMS examination with a passing score

Our Commitment

Rooted in our Mission and Core Values, we honor the dignity of every person and recognize the unique perspectives, experiences, and talents each colleague brings. By finding common ground and embracing our differences, we grow stronger together and deliver more compassionate, person-centered care. We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other status protected by federal, state, or local law.

Design and Mechanical Engineer – Medical Devices

Join a global leader medical device company. Design and manufacture technology used in spine and orthopedic surgeries

You will work on the design and development of surgical implants and instruments, collaborating with engineers, surgeons, and cross-functional teams to bring innovative products to market.

Full‑time | W2 | M-F 8am- 5pm | On site Audubon PA (outside of Philadelphia)

Qualifications

• 4+ years of mechanical and medical device design engineering experience.
• II and III medical device experience
• Experience with CREO or SolidWorks for mechanical design and documentation.
• Experience working within regulated environments (ISO 13485 / FDA).
• Ability to work in both engineering and clinical environments, including operating rooms and labs
• Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, Bioengineering, or related field.

Benefits:

Visa sponsorship supported within US

W2 contract

Audubon, PA (outside Philadelphia)

Bonus for relocation within US and annual bonuses

Work directly with surgeons

Full product development lifecycle exposure

Key Responsibilities

Product Development

• Lead the design and development of surgical instruments and implants using CAD software (CREO).
• Develop and maintain project plans and FDA-compliant Design History Files (DHF).
• Perform design verification and validation to ensure designs meet technical specifications.
• Manage assigned projects to ensure timely completion while maintaining compliance with regulatory requirements.
• Collaborate with internal prototype teams and external vendors for rapid prototyping and testing.
• Support preparation of regulatory submissions to the FDA.

Customer Engagement

• Work directly with surgeons and clinical users to gather product feedback and translate clinical needs into design requirements.
• Participate in product launches, sales training, and customer visits.
• Support surgical cases in the operating room to observe device performance and identify opportunities for improvement.

Cross-Functional Collaboration

• Partner with marketing and product management to develop market strategies and forecasts.
• Collaborate with operations and manufacturing to support production and commercialization.
• Conduct competitive and industry research to ensure innovative product development.

Product Lifecycle & Sustaining

• Support the lifecycle management of commercialized products.
• Drive design improvements, cost reduction initiatives, and engineering changes.
• Work closely with Quality, Regulatory, Manufacturing, and Supply Chain teams to ensure product performance and compliance.

The IN group is here to support you specifically with the recruitment and hiring process for job opportunities. Our role is focused on guiding you through these steps. If you have any questions related to your application or next steps in the hiring process,

Apply, and please feel free to reach out.

ANEUVO is developing breakthrough neuromodulation devices and bioelectronic medicine to treat diseases and injuries that are incurable with conventional pharmacological agents. We are building a cohesive team with complementary and multidisciplinary expertise to develop and bring our products to market.

We are currently looking for a detail-oriented and reliable Production Operator / Technician to join our manufacturing team in producing high-quality medical devices. You will be responsible for operating equipment, assembling components, inspecting products, and ensuring adherence to strict regulatory standards such as ISO 13485 and FDA cGMP.

Key Responsibilities:

• Operate and monitor production equipment according to SOPs (Standard Operating Procedures)
• Assemble medical device components manually or using automated tools
• Perform in-process inspections and testing to ensure product quality
• Maintain accurate records of production output, defects, and downtime
• Follow Good Manufacturing Practices (GMP), cleanroom protocols, and safety guidelines
• Participate in root cause analysis and continuous improvement activities
• Support equipment maintenance, calibration, and troubleshooting
• Collaborate with quality, engineering, and warehouse teams to meet production goals

Qualification:

• High School diploma or GED required; Associate degree or technical certification preferred
• 3 to 5 years of experience in a manufacturing environment, preferably medical device or pharmaceutical
• Basic knowledge of GMP, ISO 13485, and cleanroom standards
• Ability to read technical drawings, work instructions, and production schedules
• Strong attention to detail and manual dexterity
• Ability to stand for long periods and lift up to 30 lbs
• Comfortable working in controlled environments

Preferred Qualification:

• Experience with medical device assembly
• Familiarity with electronic batch records (EBR) and ERP systems
• Ability to work effectively in a team-oriented, fast-paced environment
• Good written and verbal communication skills

What we offer:

• A unique opportunity to drive a revolution in medical practices and to significantly improve the health condition of patients
• A unique environment for you to exercise your talents and be impactful
• Medical, dental and vision insurance
• Employee stock options

Last but not least, we are a small team and thus everyone plays a critical role - your voice will be heard clearly and loudly! Come join us and build the future, today.

Our firm has a Clinical Specialist position in based in the Medford area for one of the fastest growing divisions of a Top Company we are looking for individuals with either clinical or Med Device experience that want to make the move into an exciting field clinical Sales role.

Territory is Medford and surrounding

First year earnings will be $90K-110K (75K+ Base salary plus bonus) DOE with opportunity to advance quickly. You will also receive a monthly car allowance of $500 plus gas, a travel expense account, great benefits package, retirement, incentive plans, paid vacation etc.

You will be trained to become an expert on this particular Medical Device. You will be working with the patients before during and after surgeries. This amazing device is surgically implanted inside patients and is having tremendous success. You will help train patients, medical staff and Doctors on the correct use and maintenance of this device.

Provides Planned Maintenance (PM), safety testing, repairs, calibration, installation, routine and emergency service to general and various specialized diagnostic and therapeutic medical equipment, as assigned by the Clinical Engineering (CE) Manager.

Knows, understands, incorporates and demonstrates the mission, vision and core values of Trinity Health and the Ministry Organization in leadership behaviors, practices and decisions.

Performs PM procedures on multiple types of general and specialized clinical equipment.

Performs PM procedures using manufacturer’s recommendations, standards or code requirements, as well as industry acceptable processes as guidelines.

Performs corrective maintenance procedures including diagnosing problems using thermodynamic, electronic/electrical, mechanical, pneumatic, hydraulic, and/or other sciences and documents results of activities performed to comply with all regulatory and standard requirements.

Notifies equipment users, CE Managers, and Regional Director of repair status and delays as necessary.

Interacts with clinical staff to understand and resolve operational problems in scheduling and completing PM procedures while minimizing interference to hospital departments.

Determines need for replacement parts and supplies, selects the most cost effective source, and submits properly completed parts request using established policies and guidelines.

Completes corrective and planned maintenance work order documentation per policy.

Promotes teamwork by keeping others informed, participating effectively in group decision making, works to accomplish team objectives and projects, and solicits feedback about one's effectiveness as a team member.

Continually improves processes by seeking ways to eliminate and reduce waste.

Has authority (based on department guidelines)  to order parts and supplies required for emergency service or repair  of medical equipment. Recommends test equipment and spare equipment parts to the CE Manager or Lead Technician.

Provides on-call service coverage after normal business hours on a rotating basis, as assigned.

Provides assistance and training to Bio-Medical Equipment Technician I as assigned by Clinical Engineering Management.

May be assigned duties as Lead Bio-Medical Equipment Technician, as needed.

Performs other duties as assigned or requested by the CE Manager.

Maintains a working knowledge of applicable Federal, State and local laws/regulations; the Trinity Health Integrity and Compliance Program and Code of Conduct; as well as other policies and procedures in order to ensure adherence in a manner that reflects honest, ethical and professional behavior.

Minimum of an Associates of Applied Sciences Degree in related field of medical electronics, electronic technology or equivalent military or related training required.  CBET certification preferred.

Three to five years experience or equivalent, performing corrective and planned maintenance on medical devices and/or clinical support equipment. 

Must have a basic understanding of anatomy, physiology, and medical terminology.

Working knowledge and ability to use basic hand tools and  test equipment specific to the field.  Ability to train CE associates  on use and application of select test equipment.

Must have knowledge and understanding of OSHA, NFPA, The Joint Commission, CAHO, EOC, FDA and other specific regulations and standards pertaining to clinical equipment service and repair.

Must possess a personal presence that is characterized by a sense of honesty, integrity and caring with ability to inspire and motivate others to promote the philosophy, mission, vision, goals and values of Trinity Health, Ministry Organizations, and  Clinical Engineering. 

Ability to operate complex test equipment, analyze and interpret information provided by equipment and clinical staff to determine equipment operational condition.

Must have basic understanding of personal computer operation, applications, and ability to input data using keyboard.  Technician must be able to follow complex written instructions, perform tasks and document actions taken.

 Strong customer service communications skills are required to interact with hospital personnel and vendors to achieve positive outcomes. .

Ability to provide or coordinate in-service training to clinical/professional staff on medical device operations and safety functions.

Must be physically able to balance, bend, climb, crawl, crouch, kneel, reach, sit, squat, stand, twist, and walk.

Possess ability to mentally concentrate while being subject to stress, interruptions and changing work priorities.

Must be able to work and follow OSHA guidelines while in a hazardous environment(s) such as electrocution potentials, mechanical energies, bloodborne/airborne pathogens, dust and inclement weather, marked changes in temperature and/or humidity, radiation, fumes/vapors, sharp instruments/tools, hazardous liquids, and operating devices. 

Must be able to hear speech, distinguish sounds, and speak.

Must have near vision, far vision, depth perception, and be able to distinguish colors.

Must have sensory ability to distinguish hot, cold, range of temperature, surfaces, fine motor skills, manual dexterity, and detect/distinguish odors.

Must be able to carry or lift up to 50 pounds routinely (50% of the time) and on occasion (5% of the time) up to 100 pounds.

Must be able to push or pull over 100 pounds frequently (20% of the time).

Maintains safe working environment for self, other associates, patients, visitors, and medical staff in accordance with applicable standards and procedures relevant to job duties.

Must be able to adapt to frequently changing work priorities.

Must be able to travel to the various Trinity Health, Ministry Organizations, subsidiaries, and/or training facilities.

Our Commitment

Rooted in our Mission and Core Values, we honor the dignity of every person and recognize the unique perspectives, experiences, and talents each colleague brings. By finding common ground and embracing our differences, we grow stronger together and deliver more compassionate, person-centered care. We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other status protected by federal, state, or local law.

Provides Planned Maintenance (PM), safety testing, repairs, calibration, installation, routine and emergency service to general and various specialized diagnostic and therapeutic medical equipment, as assigned by the Clinical Engineering (CE) Manager.

Knows, understands, incorporates and demonstrates the mission, vision and core values of Trinity Health and the Ministry Organization in leadership behaviors, practices and decisions.

Performs PM procedures on multiple types of general and specialized clinical equipment.

Performs PM procedures using manufacturer’s recommendations, standards or code requirements, as well as industry acceptable processes as guidelines.

Performs corrective maintenance procedures including diagnosing problems using thermodynamic, electronic/electrical, mechanical, pneumatic, hydraulic, and/or other sciences and documents results of activities performed to comply with all regulatory and standard requirements.

Notifies equipment users, CE Managers, and Regional Director of repair status and delays as necessary.

Interacts with clinical staff to understand and resolve operational problems in scheduling and completing PM procedures while minimizing interference to hospital departments.

Determines need for replacement parts and supplies, selects the most cost effective source, and submits properly completed parts request using established policies and guidelines.

Completes corrective and planned maintenance work order documentation per policy.

Promotes teamwork by keeping others informed, participating effectively in group decision making, works to accomplish team objectives and projects, and solicits feedback about one's effectiveness as a team member.

Continually improves processes by seeking ways to eliminate and reduce waste.

Has authority (based on department guidelines)  to order parts and supplies required for emergency service or repair  of medical equipment. Recommends test equipment and spare equipment parts to the CE Manager or Lead Technician.

Provides on-call service coverage after normal business hours on a rotating basis, as assigned.

Provides assistance and training to Bio-Medical Equipment Technician I as assigned by Clinical Engineering Management.

May be assigned duties as Lead Bio-Medical Equipment Technician, as needed.

Performs other duties as assigned or requested by the CE Manager.

Maintains a working knowledge of applicable Federal, State and local laws/regulations; the Trinity Health Integrity and Compliance Program and Code of Conduct; as well as other policies and procedures in order to ensure adherence in a manner that reflects honest, ethical and professional behavior.

Associates of Applied Sciences degree in medical electronics, electronic technology or related field, including comparable military training or an equivalent combination of education and experience. CBET certification preferred.

Three (3) to five (5) years' experience  performing corrective and planned maintenance on medical devices and/or clinical support equipment. 

Must have a basic understanding of anatomy, physiology, and medical terminology.

Working knowledge and ability to use basic hand tools and  test equipment specific to the field.  Ability to train CE associates  on use and application of select test equipment.

Must have knowledge and understanding of OSHA, NFPA, The Joint Commission, CAHO, EOC, FDA and other specific regulations and standards pertaining to clinical equipment service and repair.

Must possess a personal presence that is characterized by a sense of honesty, integrity and caring with ability to inspire and motivate others to promote the philosophy, mission, vision, goals and values of Trinity Health, Ministry Organizations, and  Clinical Engineering. 

Ability to operate complex test equipment, analyze and interpret information provided by equipment and clinical staff to determine equipment operational condition.

Must have basic understanding of personal computer operation, applications, and ability to input data using keyboard.  Technician must be able to follow complex written instructions, perform tasks and document actions taken.

 Strong customer service communications skills are required to interact with hospital personnel and vendors to achieve positive outcomes. .

Ability to provide or coordinate in-service training to clinical/professional staff on medical device operations and safety functions.

Must be physically able to balance, bend, climb, crawl, crouch, kneel, reach, sit, squat, stand, twist, and walk.

Possess ability to mentally concentrate while being subject to stress, interruptions and changing work priorities.

Must be able to work and follow OSHA guidelines while in a hazardous environment(s) such as electrocution potentials, mechanical energies, bloodborne/airborne pathogens, dust and inclement weather, marked changes in temperature and/or humidity, radiation, fumes/vapors, sharp instruments/tools, hazardous liquids, and operating devices. 

Must be able to hear speech, distinguish sounds, and speak.

Must have near vision, far vision, depth perception, and be able to distinguish colors.

Must have sensory ability to distinguish hot, cold, range of temperature, surfaces, fine motor skills, manual dexterity, and detect/distinguish odors.

Must be able to carry or lift up to 50 pounds routinely (50% of the time) and on occasion (5% of the time) up to 100 pounds.

Must be able to push or pull over 100 pounds frequently (20% of the time).

Maintains safe working environment for self, other associates, patients, visitors, and medical staff in accordance with applicable standards and procedures relevant to job duties.

Must be able to adapt to frequently changing work priorities.

Must be able to travel to the various Trinity Health, Ministry Organizations, subsidiaries, and/or training facilities.

Our Commitment

Rooted in our Mission and Core Values, we honor the dignity of every person and recognize the unique perspectives, experiences, and talents each colleague brings. By finding common ground and embracing our differences, we grow stronger together and deliver more compassionate, person-centered care. We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other status protected by federal, state, or local law.

Our client is a premier supplier of medical device solutions for major OEMs, delivering a broad portfolio of metal-fabricated products and silicone-handled components. Their capabilities support the production of surgical implants, robotics, orthopaedic devices, and other advanced medical technologies.

Plan, coordinate, and execute quality control programs ensuring compliance to ISO13485 and FDA standards. Investigate and address customer complaints - CAPA. Assist with preparing and executing internal and external audits. Handle document and process controls. Update documentation and data within the QMS. Create and direct validations (IQ/OQ/PQ). Create PPAP documentation. Other duties as assigned.

MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.

5-7+ years of quality experience in medical device. Understanding of ISO13485 and FDA standards. Experience with metal fabrication, CNC preferred. GD&T/PPAP experience. Knowledge of QMS software and associated document control. Certifications a plus. Bachelors degree a plus. Sponsorship is not provided.

Salary ranging from $80,000-$100,000 depending on experience and interviews. 3 weeks of PTO- accrues from day one. Full medical benefit plans offered on day one. Discretionary bonus. Company paid holidays. 401(k) matching.

At a Glance

Company: Karl Storz
Location: Franklin, MA (On-site)
Job Type: Full-Time
Pay Range: $97,900 – $127,400 per year (DOE)
Shift: Day Shift | Monday – Friday
Overtime: As Needed
Experience Level: Senior (5+ years machining/manufacturing experience)
Education: Bachelor’s Degree Required (Mechanical or Industrial Engineering)
Industry: Medical Device Manufacturing
Apply: Directly through hireCNC

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Why This Role Exists

This role exists to support ongoing product innovation, process optimization, and production scalability within a high-precision medical manufacturing environment.

At Karl Storz, this Process Engineer plays a key role in developing, improving, and sustaining CNC machining processes used to produce complex surgical components — ensuring efficiency, quality, regulatory compliance, and long-term manufacturability.

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The Work You’ll Be Doing

In this role, you will:

• 
  
• Develop machining processes and operation sheets from engineering data
  
• Implement new manufacturing methods, tooling, and equipment improvements
  
• Optimize processes for quality, efficiency, and cost reduction
  
• Design assembly tooling, jigs, fixtures, and production aids
  
• Lead cross-functional projects from concept through implementation
  
• Analyze manufacturing data and drive corrective actions with Quality teams
  
• Evaluate outside processes and vendors for performance and reliability
  
• Support capacity planning and equipment selection decisions
  
• Create clear documentation to support production and compliance
  
• Train personnel and provide daily technical support to production teams
  
• Ensure compliance with FDA, ISO 13485, ISO 9001, and GMP standards
  

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Machines, Controls & Manufacturing Environment

You’ll support machining operations involving:

Equipment: Multi-axis CNC mills, lathes, and precision machining systems
Inspection Tools: CMM, profilometers, vision systems, precision metrology equipment
Process Tools: SPC methods, Lean manufacturing techniques
ERP Systems: SAP, Oracle, or similar

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Materials You’ll Work With

• 
  
• Stainless Steel
  
• Nitinol
  
• Nickel Alloys
  
• Other medical-grade materials
  

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What We’re Looking ForRequired:

• 
  
• Bachelor’s degree in Mechanical or Industrial Engineering
  
• 5+ years of manufacturing or machining-related experience
  
• Strong knowledge of CNC machining processes and equipment
  
• Proficiency with GD&T and precision metrology
  
• Experience developing and improving manufacturing processes
  
• Strong documentation and project management skills
  
• Ability to manage multiple priorities in a regulated environment
  
• Excellent communication and cross-functional collaboration skills
  

Preferred:

• 
  
• Medical device manufacturing experience
  
• Lean Manufacturing or Six Sigma certification
  
• Fixture and tooling design experience
  
• GMP / FDA-regulated environment experience
  
• ERP experience (SAP or Oracle)
  

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Why Engineers Like Working Here

Professionals choose Karl Storz because:

• 
  
• Clean, modern, climate-controlled manufacturing facility
  
• Meaningful work supporting life-saving medical technologies
  
• Strong collaboration between engineering, production, and quality
  
• Stable workload with long-term growth opportunities
  
• Competitive salary and comprehensive benefits
  
• Tuition reimbursement (up to $5,250/year)
  
• 401(k) with 60% match on first 6%
  
• 3 weeks vacation + 11 paid holidays
  
• Up to 8 weeks fully paid parental leave
  

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Pay, Benefits & Schedule

Pay Range: $97,900 – $127,400 per year (based on experience)

Benefits Include:

• 
  
• Medical, dental, vision
  
• 401(k) with company match
  
• PTO + paid holidays
  
• Tuition reimbursement
  
• Parental leave
  
• Life, STD/LTD insurance
  
• Flexible Spending Accounts
  
• Wellness and fitness reimbursement
  
• Pet insurance options
  

Schedule:
Day Shift | Monday – Friday

Overtime: As needed

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Apply

Interested candidates can apply directly through hireCNC.

Apply Now or Save This Job to come back later.