Engineering Manager

Socket.dev; Danvers (MA); On-site; USD 178,000 - 213,000; Full time

Benefits offered by this job

Health Insurance

Dental Insurance

Vision Insurance

401(k) with employer match

Life insurance

Long-term disability

Job summary

Medtronic, Inc. in Danvers, MA seeks an Engineering Manager to lead the design and development of new medical devices, ensuring quality systems and regulatory compliance.

Lead QA/QC programs for extrusion/assembly, manage CAPA and risk assessments (PHA, PFMEA, ISO 14971), and drive continuous improvement with DMAIC and DOE, aligning with 21 CFR Part 820, ISO 13485 and EU MDR. An ideal candidate will guide IQ/OQ/PQ validations and use Minitab for analysis.

Qualifications

• Master's or Bachelor's degree in mechanical/industrial/biomedical engineering or related field.
• Minimum years of experience in quality/validation engineering for medical devices.
• Experience with regulatory standards (21 CFR Part 820, ISO 13485, EU MDR) and risk management tools.

Responsibilities

• Plan, direct and implement design and development of medical device products.
• Develop and maintain quality assurance and control systems for extrusion and assembly.
• Lead risk assessments (PHA, PFMEA, ISO 14971) and CAPA activities.
• Navigate regulatory requirements and ensure compliance across processes.
• Drive process improvement using DMAIC, RCA, 5 Whys and fishbone analysis.
• Oversee IQ/OQ/PQ validation and statistical analysis (Minitab).

Skills

Extrusion manufacturing

21 CFR Part 820

ISO 13485

EU MDR

GMP

PHA

PFMEA

ISO 14971

DMAIC

RCA

DOE

IQ/OQ/PQ

CAPA

Education

Master’s degree in Mechanical, Industrial, or Biomedical Engineering or related field

Bachelor’s degree in Mechanical, Industrial, or Biomedical Engineering or related field

Tools

Minitab

Job description

We anticipate the application window for this opening will close on - 19 Nov 2026

Position Description:

Engineering Manager for Medtronic, Inc. in Danvers, MA. 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), 5Whys, 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.

Basic Qualifications:

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, 5Whys, Fishbone, and cause mapping; DOE and process development; Process validation including IQ/ OQ/ PQ; and Statistical analysis software including Minitab.

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

The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: 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, and Simple Steps (global well-being program). The following benefits and additional compensation are available to all regular employees: 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), and 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:

https://www3.benefitsolver.com/benefits/BenefitSolverView?page_name=signon&co_num=30601&co_affid=medtronic