Provide program leadership in the development, commercialization, and transfer and sustained launch of medical devices and combination products globally
Develop and execute strategic plans for technology transfer
Provide Voice of Manufacturing input to early development teams
Author and complete regulatory filing sections, and support response to questions and pre-approval inspections
Secure early sponsorship and stakeholder alignment for projects and initiatives
Ensure that all activities are conducted with the highest regard for safety, quality, and regulatory compliance

Requirements

Technical BS degree or higher
BS or Masters in Mechanical Engineering, Chemical Engineering, Biomedical Engineering, Materials Engineering, or similar preferred
8+ years of experience in medical device or combination product engineering
Demonstrated technical leadership in Technology Transfer and Design Transfer for medical device and combination product component manufacturing, assembly, and packaging
Proven expertise in design controls, risk analysis, control strategies, design verification testing, and process validation
Exceptional project management skills and principled verbal and written communication abilities
Experience collaborating with combination product development teams and working groups

Benefits

medical, dental, vision healthcare and other insurance benefits (for employee and family)
retirement benefits, including 401(k)
paid holidays
vacation
compassionate and sick days

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills

technology transferdesign transferdesign controlsrisk analysiscontrol strategiesdesign verification testingprocess validationmedical device engineeringcombination product engineering

Soft skills

technical leadershipproject managementverbal communicationwritten communicationstakeholder alignment

Certifications

Technical BS degreeMasters in Mechanical EngineeringMasters in Chemical EngineeringMasters in Biomedical EngineeringMasters in Materials Engineering