Senior Medical Device Manufacturing Quality Engineer

PetsApp; Cambridge (MA); On-site; USD 85,000 - 110,000; Full time

Benefits offered by this job

Comprehensive benefits plan including health and dental insurance

Flexible paid time off

Career growth opportunities

Job summary

PetsApp is looking for a Senior Manufacturing Quality Engineer in Cambridge, MA to support scalable manufacturing of implantable brain-machine interface technology.

The role involves building compliant quality systems in collaboration with Manufacturing and Engineering teams.

Candidates should have 5-7 years of experience in the medical device field, particularly in FDA-regulated environments, with strong project management and regulatory skills.

Qualifications

• 5–7 years of experience in manufacturing quality or quality engineering within the medical device industry.
• Hands-on experience with process validation, equipment qualification, and manufacturing documentation.
• Experience within FDA-regulated and ISO 13485-compliant QMS environments.

Responsibilities

• Serve as the primary Quality partner for manufacturing.
• Plan and execute IQ/OQ/PQ activities for cleanroom equipment.
• Develop and review manufacturing documentation and support inspections.

Skills

Solid understanding of medical device regulations

Process control and inspection methods

Root-cause analysis tools

Strong project management skills

Ability to translate regulatory requirements

Education

Bachelor's degree in Engineering (Mechanical, Biomedical, Chemical or related field)

Job description

PetsApp is looking for a Senior Manufacturing Quality Engineer in Cambridge, MA to support scalable manufacturing of implantable brain-machine interface technology.

The role involves building compliant quality systems in collaboration with Manufacturing and Engineering teams.

Candidates should have 5-7 years of experience in the medical device field, particularly in FDA-regulated environments, with strong project management and regulatory skills.