Manufacturing Engineer (Medical Device Reporting)

Job Title: Manufacturing Engineer (Medical Device Reporting) Location: Woburn, MA Job Type: Contract W2

Scope of Job Our client is a fast-growing, dynamic global healthcare company with offices in the US and around the world. Reporting to the Global Head of Operations, the Manufacturing Engineer will use your experience and compliance knowledge to lead our clients' efforts to update and resolve gaps in their technical documentation and validation protocols.

Primary Responsibilities In preparation for MDR submissions review IQ/OQ protocols and correct any gaps to bring in compliance. Referencing BSI guidance, review technical documentation, and complete additional details to address compliance issues. Develop and execute required validations in line with regulatory requirements including Equipment, Process & Product validations. Develop Specification, Procurement, Installation, and Validation of Manufacturing Equipment, including on-site Factory Acceptance Testing of equipment. Provide ongoing day-to-day support to Production; continually seek to drive improvement in operation performance while also maintaining the highest levels of regulatory conformance. Establish and maintain appropriate Manufacturing documentation including, Equipment documentation, pFMEAs, TMVs, Bills of Materials, Part Numbers, Product routings, Manufacturing procedures and Logs. Drive FAT (Factory Acceptance Test) for Mfg. equipment necessary for internal/external Mfg. process in which the client owns the product/process design. Partner with R&D, Quality, and Operations to ensure that the transition of products through R&D, product approval, and manufacturing scale-up are smooth, timely, and cost-effective Analyze product designs for the best method of manufacture. Work collaboratively in the design, development, and/or improvement of manufacturing processes and equipment. Ensure that manufacturing has accurate and detailed information on specifications. Participate in projects to improve cost, quality, and performance of post-market products throughout cross-functional teams such as Design Assurance, Regulatory Affairs, Legal, Clinical Affairs, Marketing, and Sales ensuring the timing and effective development, planning, and implementation of product/process design changes, with Quality and Design for Manufacturing (DFM). Qualifications 5-10 years experience in a similar role Strong technical understanding of setup and maintenance of manufacturing processes. Has supported medical device qualification and validation efforts. Strong problem-solving capabilities through tools and techniques to implement systematic solutions for internal/external processes. Thorough knowledge of the current quality and regulatory requirements for medical devices required; knowledge of isotopes/radiation desired Education & Certifications Bachelor's Degree in engineering or equivalent. Please share your resumes at chaitanya@starkassociatesllc.com (or) contact : 848-277-1023