Senior Manufacturing Engineer - Woburn Massachusetts

Company: RCM Life Sciences and IT
Location: Woburn, Massachusetts
Posted On: 05/17/2024

Job Title: Senior Manufacturing Engineer
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, R&D and Regulatory Affairs. Lead the ME team in the company's relocation of the manufacturing line.
Job Type: Long Term Contract $55.00 to $65.00 plus per hour
Location: Burlington MA
Primary Responsibilities

• 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 SAT (Site Acceptance Test) for Mfg. equipment necessary for internal/external Mfg. process in which client owns the product/process design.
• Partner with R&D, Quality, Regulatory Affairs 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, with customer manufacturer under corresponding QMS (Quality Management System) Qualifications
  • BSME with 5 years or MSME with 6 years mechanical design/engineering experience or equivalent combination of education and experience.
  • Experience on Process validation protocols and reports (IOQ/PQ) from manual to automated production lines.
  • Experience with FDA, ISO, and IEC standards a plus.
  • Experience with vascular products a plus
  • Strong technical understanding of set up and maintenance of manufacturing processes.
  • Has supported medical device relocation 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 device
    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 Statement:
    RCM 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.
    
    Disclaimer:
    This 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.
    
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