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USA - Engineer II
Ref No.: 19-03184
Location: Hayward, California
 
Job Description:
 
Top 3 must haves:
 
  • Experienced in Medical Device, cGMP and/or Process Transfer
  • Lead small project teams (cross-functional) as needed to accomplish project activities
  • Excellent written and oral communication skills
 
Top Technical skills needed:
 
  • Strong problem solving skills
  • Must be able to provide solutions that reflect understanding business objectives and cost implications. This I am not sure if this is technical…
  • Knowledge or exposure to governmental regulations such as cGMPs, ISO and other regulatory requirements.
 
  • Option for role to be extended or going perm: No
  • Will they need to enter clean room? Yes
  • Potential for Exposure to Bloodborne Pathogens/Infectious Materials? Yes
  • Hours: regular Mon-Fri
  • Any overtime, if yes how many hours: Not expected
 
Engineer (focused in design)
Business Unit Advanced Surgery products
 
This position is responsible for supporting the activities of the Design Owning Organization (DOO) at the Hayward, CA facility. The candidate will work with the Hayward Product Design Owners (PDOs) in performing tasks related to regulatory compliance, change control, design control, and risk management for Advanced Surgery products produced under the Hayward DOO.
 
Essential Duties and Responsibilities
 
  • Support the PDOs in fulfilling requirements for regulatory compliance, design control and risk management activities for Biosurgery products manufactured at Hayward
  • Help ensure that design and development activities and documentation are within regulatory compliance, particularly for the new European Medical Device Regulation (MDR)
  • Help maintain the Design History Files and Risk Management files for Hayward products
  • Generate and manage work flow for appropriate change control documentation.
  • Support the PDO in gathering information from Subject Matter Experts (SMEs) and technical resources for complaint trending, complaint investigations, non-conformance investigations, change control, and regulatory submissions
  • Other tasks as needed
 
Qualifications:
 
  • Solid communication skills – both written and oral
  • Organizational skills and attention to detail
  • Ability to work effectively independently and in team environment.
  • Experience working in regulated industry (medical devices, drugs, biologics) is preferred.
  • Knowledge and experience working with medical device regulatory requirements, design control, change control, and risk management is highly desirable.
 
Education / Experience
 
  • Bachelor's degree in an engineering (discipline: Mechanical, Biomedical, Biochemical, etc.) with 1-5 years' work experience or MS with 0-2 years' experience (specifically work on medical device development through regulatory approval)
  • Software: Word, Excel (pivot tables, v-lookups, reporting), PowerPoint, SharePoint, Outlook
  • Medical Device Industry experience required
 
Interview platform: phone followed by onsite interview (at least an onsite interview)

Apply on-line for immediate consideration, please send your updated resume and contact info via
Contact: Rozina Hudda
Email: rozina@sunrisesys.com | 732-395-4460