Johnson Service Group is a nationally recognized professional staffing and recruiting firm that is currently looking for a direct hire Senior Design Assurance Engineer.
Job Location: Twin Cities - Minneapolis/St. Paul - HYBRID
Education and Experience:
Bachelor’s or advanced degree in engineering or related science, materials research, engineering or related field.
8+ years experience in product engineering, project management, quality assurance and/or regulatory positions in a medical device company, including direct experience with the development process and DHF as described in the job requirements.
Experience in a small company or start-up environment.
Job Requirements/Duties and Responsibilities:
Lead, own, create and update the design history file (DHF) including user requirements, design specifications, design verification and validation activities, test protocols and reports, and manufacturing process implementation.
Lead and implement product development projects and change requests for new products, line extensions, quality improvement initiatives, manufacturing updates, and new supplier qualifications.
Responsible for Risk Management activities from product concept through commercialization.
Coach and mentor the development and commercial team on design control activities.
Partner with regulatory to support and create content for US regulatory submissions for 510k clearance and pre-market authorizations.
Work with contract research organizations and test facilities to develop and execute pre-clinical and clinical test plans.
Work closely with contract manufacturers and other suppliers to implement new projects and ensure supply chain meets performance and quality requirements.
Participate and/or assist with cross training activities, training of new hires and temporary staff. Follow set training program for position and ensure training requirements are up to date using training tracking system.
Support external audits (ISO and FDA).
Performs other related duties and responsibilities, as assigned.
** Johnson Service Group (JSG) is an Equal Opportunity Employer. JSG provides equal employment opportunities to all applicants and employees without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, marital status, protected veteran status, or any other characteristic protected by law.
Lead, Implement, Development, Design Verifications and Validation, Risk Management, Protocol,