10 days old

Design/Quality Assurance Engineer - Medical Device

Bose Corporation
Boston, MA 02109
  • Job Code
    R21159-1
Job Description
The Medical Device Design Assurance Engineer will focus on accelerating technical deliverables related to medical device design and development. The Medical Device Design Assurance Engineer will also support sustaining engineering activities and provide support to the Quality organization for quality initiatives including process improvements, corrective and preventative actions, supplier corrective actions and post market activities. This role will be embedded in an emerging business with a dynamic and exciting growth path.

Develops and implements methods and procedures for process control, process improvement, testing and inspection to ensure that the products are free of flaws and function as designed. Analyzes reports and defective products to determine trends and recommend corrective actions. Collaborates with supplier representatives on quality problems, ensures that effective corrective actions are implemented, and contributes to supplier quality improvement programs.

RESPONSIBILITIES

  • Review, create and edit design control documents for medical devices with integrated hardware and software in accordance with the QMS system and applicable regulations
  • Interact with other cross functional divisions and research and development groups to jointly develop objectives and align on product development plans
  • Participate in meetings and efforts to gather data and work towards resolution of project development and launch issues as they relate to areas of DAE expertise
  • Assist in the preparation, review and approval of design verification test protocols, procedures, and reports
  • Drive risk management activities and documentation inclusive of risk management planning, hazard analysis, FMEAs, and reports to inform product design in accordance with ISO 14971
  • Assist engineering in the compilation of design history files to conform to the requirements of ISO 13485 and 21 CFR 820.30.
  • Serve as the advocate for the quality and the quality management system during product design and development to ensure all applicable deliverables and decisions are derived and documented in accordance with the governing regulations, policies, and procedures
  • Support ISO 13485 certification, CAPAs and audits (internal and external)
  • Work with Joint Development Manufacturing (JDM) partners to establish design assurance requirements, including validation testing and product certification standards, and oversee their successful execution.
  • Participate in product changes, design reviews, and relevant project meetings as the quality representative
  • Ensure that design and process changes comply with product requirements, required standards and regulations.
  • Review and approve design control documents and design changes
  • Provide expertise, guidance, and training within area of responsibility to the organization
  • Performs other duties as assigned.
  • Ensure compliance with the Bose Quality Management System, 3rd party accreditation, and FDA regulatory requirements

QUALIFICATIONS
  • BS in Engineering, Bioengineering with at least 2 years of experience working with medical device design, FDA, ISO or other regulated environment and/or equivalent combination of education and experience.
  • Familiarity with Quality Management Systems and the requirements of ISO 13485,
  • Familiarity with the principles of risk management and ISO 14971, as well as other industry standards such as IEC 60601-1, and ISO 62366
  • Experience in product & process development
  • Strong organization skills and attention to detail
  • Self-starter with the ability to learn and operate independently
  • Tactful and team oriented with solid coaching skills
  • Strong writing and communication skills

#LI-PM1

#LI-PM1

Bose is an equal opportunity employer that is committed to inclusion and diversity. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status, or any other legally protected characteristics. For additional information, please review: (1) the EEO is the Law Poster (http://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf); and (2) its Supplements (http://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm). Please note, the company's pay transparency is available at http://www.dol.gov/ofccp/pdf/EO13665_PrescribedNondiscriminationPostingLanguage_JRFQA508c.pdf. Bose is committed to working with and providing reasonable accommodations to individuals with disabilities. If you need a reasonable accommodation because of a disability for any part of the application or employment process, please send an e-mail to Wellbeing@bose.com and let us know the nature of your request and your contact information.





Posted: 2021-10-08 Expires: 2021-11-06
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Design/Quality Assurance Engineer - Medical Device

Bose Corporation
Boston, MA 02109

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