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JBL Resources

System Engineer

JBL Resources, Ann Arbor, Michigan, us, 48113

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About the Company Our Hiring Company, a best-in‑class medical device manufacturer, has an opening for a new team member at their facility. Holding itself to the highest standards of integrity, quality and excellence, this company has contributed to the healthcare industry for over 90 years and has been rated as a Forbes top 14 most innovative companies in the world. With a strong vision for making medical treatments easier on its patients, this company gears its technological innovations from its top‑talented engineers toward making a significant contribution to our society.

Key Responsibilities

Managing the design control processes by developing and maintaining comprehensive documentation throughout the product lifecycle.

Collaborating with cross‑functional teams to gather and translate user needs into detailed product requirements.

Conducting risk assessments and implementing risk management strategies to ensure product safety and compliance.

Performing design verification and validation activities to confirm that products meet specified requirements.

Updating product labeling and ensuring all documentation reflects current design and regulatory standards.

Supporting continuous improvement initiatives by reviewing and refining design processes and documentation practices.

Qualifications

Bachelor’s degree in Biomedical Engineering, Mechanical Engineering, or related field (Master’s preferred).

Minimum of 3–5 years of experience in design controls or related roles within the medical device industry.

Experience managing documentation for regulatory submissions and product lifecycle management.

Proven experience in design control processes within medical device development.

Strong knowledge of FDA and ISO 13485 regulations related to design documentation, risk management, and verification/validation.

Excellent documentation skills, with an eye for detail and accuracy.

Ability to analyze and translate user needs into technical specifications.

Experience collaborating with cross‑functional teams including regulatory, manufacturing, and R&D.

Interested candidates please apply on our website at https://jobs.jblresources.com.

For more information about our services and great opportunities at JBL Resources, please visit https://www.jblresources.com.

JBL is an Equal Opportunity Employer and E-Verify Company.

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