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R&D or Quality Engineer (FEMEA Design verification testing Mech/Biomed

Employer
ATR International, Inc.
Location
Saint Paul
Salary
Competitive

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RD or Quality Engineer (FEMEA Design verification testing Mechanical or Biomedical Engg.) Contract to hire role Direct Client medical device company Looking for 3-5 years of experience in and RD or Quality role BA or BS in Mechanical engineering or biomedical. Looking for contract to hire. Written protocol and coordinating testing development quality support risk management support FEMEA Design verification testing Coordinating testing Writing protocol experience Leadership experience, working with technician level and higher Top requirements Problem solving. Root cause investigation. Great communication skills Good documentation and writing skills Protocol development experience. Must have attention to detail. Data analysis Core team experience Open to relocation, but needs to relocate immediately Years Experience 2 - 5 years Skills Verbal and written communication, interpersonal, team work, individual contributor, multi task, strong organizational, advanced computer skills Education Bachelor level degree in an Engineering Discipline or Biomedical Duties Participate in or lead teams in supporting quality disciplines, decisions, and practices, lead on-time completions of design control deliverables, support on-time execution of Quality Plans for internal product development process (PDP), OEM-based Clinical Product Development (CPDP) and design change projects, accountable for generation of PDP design verification test plansreports for productsystem requirements, lead or support Risk Management activities from product concept through commercialization, including generation of risk management plansreports, completion and maintenance of hazard analysis, FMECA's and Cybersecurity risk assessments, lead identification of essential outputs and generate Essential Output reports, accountable for completion of labeling verification activities and labeling verification reports, work with design engineering in the completion of customersystemproduct requirements, work with design engineering in the completion of product verification and validation, endure DHF content completion, integrity and regulatory standards compliance, collaboratively communication resolving gaps, complete document change request reviews in a timely and objective manner, identify and implement effective process control systems to support the development, qualification and on-going manufacturing of products to meet or exceed internal and external requirements, assist in the implementation of assurances, process controls and CAPA systems designed to meet or exceed internal and external requirements, assist in the development and execution of streamlined business systems which effectively identify and resolve quality issues, apply sound, systematic problem solving methodologies in identifying, prioritizing, communicating and resolving quality issues, support all company initiatives as identified by management and in support of quality management systems (QMS), Environmental Management Systems (EMS) and other regulatory requirements.

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