Manufacturing Engineer (Medical Device Reporting)

Company: RCM Technologies
Location: Woburn
Posted on: September 25, 2022

Job Description:

Job Title: Manufacturing Engineer (Medical Device Reporting) Job Function: The Manufacturing Engineer will drive Engineering requirements within our medical device client's Operations team and play an active part in cross functional support, including Quality and R&D. Lead the team in its attempt to be complaint in preparation for successful EU MDR submissions.Job Type: Contract or Contract to HireLocation: Hybrid/RemoteScope of JobOur 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 to include 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 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 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 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 set up 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 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. About RCM:RCM IT & Life Sciences is a leading provider of IT Business Solutions and Engineering Services to over 1,000 clients in the commercial and government sectors. RCM partners with clients to define implement and manage a broad range of technologies across multiple platforms, systems, and networks. Our broad geographic presence ensures that a proven and reliable tactical and strategic capability is available and deployable virtually everywhere in North America.Equal Opportunity StatementRCM is 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, or status as a protected veteran.DisclaimerThis job description is intended to describe the general nature and the level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. RCM reserves the right to amend and change responsibilities to meet business and organizational needs, as necessary.

Keywords: RCM Technologies, Boston , Manufacturing Engineer (Medical Device Reporting), Healthcare , Woburn, Massachusetts