Engineering Manager

Position Description

Plan, direct and implement various aspects of the design and development of new medical device products. Develop, evaluate, implement and maintain technical quality assurance and control systems standards in extrusion and assembly manufacturing pertaining to materials, techniques, and products. Select, develop and evaluate personnel to ensure the efficient operation of the function. Leverage Quality Engineering for medical device components meeting specifications.

Navigate government and industry regulations to include 21 CFR Part 820 Quality System Regulation (QSR), ISO 13485, European Union (EU) Medical Device Regulation (MDR), State of the Art (SOTA) and Good Manufacturing Practices (GMP). Manage Risk Assessments including Preliminary Hazard Analysis (PHA), Process Failure Mode Effect Analysis (PFMEA) and ISO 14971 Risk Mgmt. for Medical Devices. Manage the Non‑Conformances, Complaints and Corrective and Preventive Actions (CAPA).

Leverage Process Improvement Tools including Define, Measure, Analyze, Improve, and Control (DMAIC), Root Cause Analysis (RCA), 5

Whys, Fishbone and cause mapping. Leverage Design of Experiments (DOE) methods to establish process development and Minitab for statistical analysis. Manage product validation to include Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). Implement inspection optimization improvement projects. Relocation assistance is not available for this position. #LI‑DNI.

• Master’s degree in Mechanical, Industrial, or Biomedical Engineering or related engineering field and three (3) years of experience as a quality/validation engineer or related occupation in quality engineering for medical devices
• or alternatively, Bachelor’s degree in Mechanical, Industrial, or Biomedical Engineering or related engineering field and five (5) years of experience as a quality/validation engineer or related occupation in quality engineering for medical devices.
• Must possess at least three (3) years’ experience with each of the following:
  • Extrusion and assembly manufacturing
  • 21 CFR Part 820, ISO 13485, EU MDR, SOTA, and GMP
  • PHA, PFMEA, and ISO 14971
  • Non‑Conformances and CAPA
  • DMAIC, RCA, 5
    
    Whys, Fishbone, and cause mapping
  • DOE and process development
  • Process validation including IQ/ OQ/ PQ
  • Statistical analysis software including Minitab

Salary: $178,000 to $213,000 per year

• Health, Dental and vision insurance
• Health Savings Account
• Healthcare Flexible Spending Account
• Life insurance
• Long‑term disability leave
• Dependent daycare spending account
• Tuition assistance/reimbursement
• Simple Steps (global well‑being program)

• Incentive plans
• 401(k) plan plus employer contribution and match
• Short‑term disability
• Paid time off
• Paid holidays
• Employee Stock Purchase Plan
• Employee Assistance Program
• Non‑qualified Retirement Plan Supplement (subject to IRS earning minimums)
• Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)

Regular employees are those who are not temporary, such as interns.

Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan.

Please note some of the above benefits may not apply to workers in Puerto Rico.

Further details are available at the link below:

We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people. We are engineers at heart— putting ambitious ideas to work to generate real…