Software Engineer

JBL Resources • Ann Arbor, MI • 2h ago

Software Engineer Location: Ann Arbor, Michigan About Our Client: 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 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 towards making a significant contribution to our society. Key Responsibilities:

Representing Quality on product development teams to ensure compliance with internal procedures and U.S. and international regulatory requirements.

Leading quality system development and implementation throughout the product lifecycle.

Providing focused quality engineering support and driving timely execution of assigned project activities.

Leading Risk Management activities, including authoring risk management plans and reports, facilitating FMEA sessions, and ensuring risk assessments occur at appropriate project phases.

Leading master validation planning sessions and reviewing/approving validation and qualification documentation.

Reviewing and approving technical transfer plans and supporting design transfer activities to manufacturing.

Providing input to material specifications, drawings, inspection procedures, and manufacturing documentation to ensure manufacturability and testability.

Overseeing metrology, incoming inspection, acceptance criteria, and disposition of non-conforming materials.

Participating in supplier selection and component specification reviews, and acting as a technical quality liaison for supplier-related issues.

Developing and validating quality test methods.

Establishing and leading corrective and preventive action (CAPA) plans and quality assurance strategies.

Reviewing quality history, supplier controls, scrap analysis, and process controls to drive defect prevention initiatives.

Monitoring field quality performance, analyzing field returns, and determining root cause.

Tracking quality trends, managing corrective actions, and driving continuous improvement efforts.

Generating and maintaining quality documentation including quality plans, SOPs, and inspection procedures.

Participating in Product Review Boards and leading investigations into internal and external complaints.

Applying structured problem-solving methodologies to identify, prioritize, and resolve quality issues.

Providing training and mentorship on quality system processes and best practices.

Qualifications:

Bachelor's degree in Engineering, Life Sciences, or a related technical discipline required.

4--6 years of experience in Product Development or R&D within a regulated environment.

6--10 years of progressive experience in a medical device quality assurance environment.

Strong working knowledge of engineering fundamentals and their application in product development and manufacturing.

Auditor experience preferred (1--2 years).

Demonstrated knowledge of 21 CFR 820, ISO 13485, ISO 14971, and other applicable medical device regulations and standards.

Experience with quality tools and statistical methodologies including FMEA, DOE, SPC, and Minitab.

Interested Candidates please apply on our website at https://jobs.jblresources.com{cke-saved-href="https://jobs.jblresources.com"}. For more information about our services and gre

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