Product Transfer Engineer

Job Description

Insight Global is hiring an experienced Manufacturing Transfer Engineer to support the transfer of orthopedic medical devices into manufacturing for our client in Raynham, MA. This role will focus on authoring and managing manufacturing transfer documentation, leading change control activities, supporting verification and validation efforts, and developing product and packaging stability strategies. The ideal candidate will collaborate closely with quality, regulatory, and manufacturing teams to execute project deliverables and achieve key program milestones.

Responsibilities -Author and manage Change Control Plans (CCPs) and Change Control Reports (CCRs) to support manufacturing transfer initiatives. -Lead cross-functional change control activities and drive alignment across stakeholders to meet project timelines. -Develop and document Verification & Validation (V&V) strategies, rationales, and supporting plans. -Create product and packaging stability and shelf-life strategies to support regulatory and quality requirements. -Develop and maintain Manufacturing Transfer Plans and associated project documentation. -Update requirements documents and traceability matrices to ensure alignment throughout the product lifecycle. -Review and approve process verification and process validation documentation and activities. -Utilize PLM and document management systems to review, route, approve, and maintain technical documentation. -Participate in cross-functional project meetings and provide technical input to support project execution. -Support the development of protocols, reports, and technical assessments. -Perform and document benchtop and simulated-use testing activities as required. -Contribute to issue resolution, risk assessments, and continuous improvement efforts throughout the transfer process.

Compensation: $60/hr to $70/hr. Exact compensation may vary based on several factors, including skills, experience, and education. Employees in this role will enjoy a comprehensive benefits package starting on day one of employment, including options for medical, dental, and vision insurance. Eligibility to enroll in the 401(k) retirement plan begins after 90 days of employment. Additionally, employees in this role will have access to paid sick leave and other paid time off benefits as required under the applicable law of the worksite location.

Skills and Requirements

-Bachelor's degree in Engineering or a related technical discipline. -5+ years of experience within the medical device industry. -Demonstrated experience supporting manufacturing transfer, product lifecycle, or design change projects. -Strong knowledge of change control processes, including authoring and execution of Change Control Plans and Change Control Reports. -Experience leading cross-functional teams and coordinating efforts across multiple functional groups. -Familiarity with verification and validation methodologies, process validation, and technical documentation. -Experience working with PLM or document management systems. -Proficiency with Microsoft Office Suite, including Word, Excel, and PowerPoint. -Strong written and verbal communication skills. -Highly organized with strong attention to detail and the ability to manage multiple priorities. Preferred Qualifications -Experience with orthopedic medical devices or other Class II/III medical products. -Experience using Windchill or similar PLM systems. -Familiarity with technical drawings and engineering documentation. -Exposure to Creo CAD or similar CAD platforms. -Prior experience authoring manufacturing transfer documentation, V&V strategies, stability plans, and technical reports. -Experience supporting shelf-life, packaging validation, or product stability programs.

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal employment opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment without regard to race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to [email protected].