Engineering Manager, Medical Devices Quality & Compliance

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

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.