Senior Process Development Engineer - Medical Devices

Integer Holdings Corporation; Plymouth (MN); On-site; USD 96,000 - 141,000; Full time

Benefits offered by this job

Medical, dental, vision

401(k) with company match

Parental leave

Paid holidays

Adoption benefits

Job summary

Integer Holdings Corporation in Plymouth, MN, seeks an Engineer III to apply engineering knowledge to support process development, manufacturing, and product realization. You will lead workstreams and act as the primary technical lead on selected projects, ensuring quality, safety, and regulatory compliance.

The role requires 5–8 years in medical device manufacturing, with experience in cleanroom assembly, laser and resistance welding, injection and silicone molding, and sterile packaging.

Qualifications

• Bachelor's degree in Engineering or a related technical field.
• 5–8 years of engineering experience in medical device manufacturing.
• Hands-on experience with cleanroom assembly and related technologies.
• Familiarity with IQ/OQ/PQ and TMV validation activities.
• Strong analytical and problem-solving skills and familiarity with Six Sigma tools.

Responsibilities

• Support process development activities for new product introduction and transfers.
• Execute process characterization studies and validation activities (IQ/OQ/PQ/TMV).
• Investigate manufacturing issues, perform root cause analysis, and implement CAPAs.
• Collaborate with Quality, Manufacturing, R&D, Regulatory, and Supply Chain teams.

Skills

Cleanroom assembly

Laser welding

Resistance welding

Injection molding

Silicone molding

Sterile packaging

Statistical analysis

Design Controls

TMV (Test Method Validation)

Six Sigma/Root Cause Analysis

Education

Bachelor's degree in Engineering

Tools

QMS

Job description

Integer Holdings Corporation in Plymouth, MN, seeks an Engineer III to apply engineering knowledge to support process development, manufacturing, and product realization. You will lead workstreams and act as the primary technical lead on selected projects, ensuring quality, safety, and regulatory compliance.

The role requires 5–8 years in medical device manufacturing, with experience in cleanroom assembly, laser and resistance welding, injection and silicone molding, and sterile packaging.