Senior Medical Device Quality Engineer — Design Controls

Fresenius Kabi USA; Massachusetts; Hybrid; USD 160,000 - 170,000; Full time

Benefits offered by this job

401(k) plan with company contributions

Paid vacation and personal days

Health benefits including medical, dental, and vision coverage

Job summary

A prominent healthcare organization seeks an Engineering Specialist, Quality to support quality assurance processes for medical devices. This role involves developing compliance with industry standards and overseeing the testing of software and hardware systems. Candidates should have over 10 years of experience in the medical device industry, along with leadership and communication skills. The position offers a competitive salary range of $160,000 - $170,000 and hybrid work options in Massachusetts.

Qualifications

• 9+ years of experience in medical device industry or equivalent.
• Knowledge of IEC/ISO 62304 and 21 CFR 820.30.
• Experience with FDA regulations for medical device software.

Responsibilities

• Develop and implement quality assurance processes.
• Assure thorough testing and validation of systems.
• Collaborate with teams to define quality metrics.

Skills

Quality assurance processes

Knowledge of industry standards

Leadership skills

Communication skills

Risk management

Mentoring

Education

Bachelor’s degree in Engineering or related field

Associates degree with 15+ years of experience

Job description

A prominent healthcare organization seeks an Engineering Specialist, Quality to support quality assurance processes for medical devices. This role involves developing compliance with industry standards and overseeing the testing of software and hardware systems. Candidates should have over 10 years of experience in the medical device industry, along with leadership and communication skills. The position offers a competitive salary range of $160,000 - $170,000 and hybrid work options in Massachusetts.