Find & Apply For Manufacturing Engineer Jobs in Allegan, Michigan

At Perrigo, we are driven by our mission to Makes Lives Better Through Trusted Health and Wellness Solutions, Accessible to All. We are proud to be a Top 10 player in the European Consumer Self-Care market and the largest U.S. store brand provider of over the counter and infant formula. Dedicated to providing The Best Self-Care for Everyone, we are the people behind the brands you trust. We are Opill®, Compeed®, Solpadeine®, NiQuitin®, and many more. We Are Perrigo. We are committed to enhancing the wellbeing of our colleagues and consumers alike. We pride ourselves on fostering an inclusive, collaborative culture where each person can experience a sense of belonging. Join us on our One Perrigo journey as we evolve to win in self-care.

Description Overview

The Pre-Commercial Quality Professional - Medical Devices is an individual contributor responsible for providing Quality leadership and subject matter expertise for medical device and combination-product development from concept through market launch. This role provides independent Quality oversight and partners with cross-functional teams to ensure design controls, risk management, verification and validation, design transfer, and launch-readiness activities meet applicable regulatory requirements, internal procedures, and product quality objectives. Scope of the Role

• Provide independent Quality oversight for medical device and device constituent-part development from concept and feasibility through design transfer, regulatory submission support, commercialization, and post-launch handoff.
  
• Ensure development activities comply with applicable Perrigo procedures, FDA 21 CFR Part 820/QMSR, ISO 13485, ISO 14971, EU MDR, and other applicable global requirements.
  
• Provide Quality oversight of design controls, including user needs, design inputs and outputs, design reviews, verification and validation, design changes, traceability, design transfer, and design and development documentation.
  
• Oversee product and process risk-management activities and ensure identified risk controls are appropriately implemented, documented, and verified.
  
• Serve as the Quality representative for project governance, stage-gate, design-review, and launch-readiness activities, assessing Quality deliverables and risks before project progression.
  
• Review and approve applicable design and development documentation, including requirements, specifications, protocols, reports, risk-management files, verification and validation evidence, usability, software, biocompatibility, packaging, shelf-life, sterilization, and design-transfer documentation.
  
• Partner with R D, Engineering, Regulatory Affairs, Clinical, Operations, Supply Chain, Procurement, Commercial, Human Factors, and external partners to incorporate Quality requirements throughout development.
  
• Provide Quality oversight of external development partners, contract manufacturers, laboratories, and critical suppliers, including qualification, Quality Agreements, audits, technical reviews, issue escalation, and performance monitoring.
  
• Ensure manufacturing processes, test and inspection methods, tooling, packaging, labeling, sterilization, supplier controls, and other applicable processes are appropriately validated and transferred before commercial launch.
  
• Lead or support resolution of development-related deviations, nonconformities, design issues, investigations, corrective actions, design changes, and Quality risks.
  
• Assess launch readiness and ensure effective handoff to Commercial and site Quality organizations, including open risks, monitoring plans, post-market commitments, complaint considerations, and change controls.
  
• Support audits and regulatory inspections and develop procedures, tools, training, metrics, and governance necessary to strengthen medical device Quality capability.
  
• Monitor evolving medical device regulations and standards and translate requirements into practical, risk-based expectations for development programs.

Decision-Making and Authority

Exercises independent Quality judgment and may recommend that a project, design review, design transfer, or launch milestone not proceed when required evidence is incomplete or Quality, patient/consumer safety, or compliance risks are not adequately controlled. Escalates significant risks through appropriate Quality and project governance channels. This role has no direct reports. Experience Required

Education and Experience

• Bachelor's degree in engineering, life sciences, biomedical sciences, Quality, or related technical discipline; advanced degree preferred.
  
• 7+ years of progressive experience in medical device Quality, design assurance, product development, engineering, regulatory affairs, or a related regulated function, including 4+ years supporting medical device design and development.
  
• Demonstrated knowledge of design controls, risk management, verification and validation, design transfer, change control, and product commercialization.
  
• Working knowledge of

FDA 21 CFR

Part 820/QMSR, ISO 13485, ISO 14971, and applicable EU MDR requirements.

• Experience reviewing design and development documentation and participating in formal design reviews or stage-gate decisions.
  
• Strong ability to interpret technical and regulatory requirements, apply risk-based Quality judgment, and influence multidisciplinary teams without direct authority.
  
• Strong written and verbal communication skills.
  
• Ability to travel independently, including overnight travel, based on business needs.
  Preferred Qualifications
  
• Experience with combination products, consumer self-care devices, delivery systems, diagnostics, connected or software-enabled devices.
  
• Knowledge of applicable standards such as

IEC 62366-1, IEC 62304, IEC 60601-1, ISO

10993, packaging/distribution validation, sterilization, and medical device cybersecurity.

• Experience supporting 510(k), De Novo, PMA, IDE, EU technical documentation, notified-body reviews, CE marking, or other global market authorizations.
  
• Experience with external development partners, contract manufacturers, critical suppliers, supplier Quality, or technology transfer.
  
• Relevant

ASQ, RAC, ISO 13485

Lead Auditor, or comparable certification preferred.

BenefitsWe believe our people are our greatest asset. Alongside competitive compensation, we offer benefits tailored to supporting you and your family, as well as career development opportunities to ensure you feel valued and supported, both professionally and personally.

Find out more about Total Rewards at Perrigo. We are proud to be included in the Forbes list of "America's Best Employers by State 2024". Find out more here Applicants please note: To apply to this position please click the APPLY button at the bottom of the application. (The SAVE button will only save your profile information but not submit an application for this open position.) All application materials, including resumes and CVs, must be submitted in English. Thank you. We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or other characteristics protected by law. #weareperrigo