Device Engineer

1 month ago


Other US Location Genentech Full time

A healthier future. It's what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That's what makes us Genentech, a member of the Roche Group.

In the Global Device and Packaging Development Department (PTDZ), we are responsible for the development of innovative device technologies and packaging systems, ensuring a superior experience for patients and healthcare providers with Roche products. We do this through innovative technologies & solutions, agile execution of development plans, collaborative partnerships with internal/external stakeholders, and diverse & talented teams committed to meeting patient needs.

The Opportunity:

  • Plan, execute, and document equipment qualification, computer system validation, and test-method development/validation projects in accordance with cGMP requirements.
  • Draft, review and/or approve design control documents (i.e. DHF documents) to support device development deliverables, participate in hazards analysis, design assessments, and reviews.
  • Provide guidance and input on product development and commercializing devices, including interfaces with the primary container.
  • Collaborate with internal teams (Commercial Marketing, Clinical Sciences, Contract Manufacturing, etc.), external development partners, component suppliers, and lab equipment suppliers.
  • Ensure compliance with Roche Pharma Quality Policy and Pharma Quality System (PQS), including owning and assessing changes and discrepancies, and assist in resolving issues from quality assessments, audits, and regulatory inspections.

Who You Are

Required

  • You have B.S, M.S, or advanced degree in Engineering, with preference for Mechanical Engineering, Materials Science Engineering, Electrical Engineering, Chemical Engineering, or equivalent.
  • You have approximately 3-5 years of experience in the industry and/or academia (including advanced studies) after receiving their Bachelor's degree.
  • You have experience in the Pharmaceutical, Biotech or Medical Device industry with previous work on development of injection devices.
  • You have experience within some or all of the following: test and setup fixture design, CAD, Rapid prototyping, GD&T, Material selection & Biocompatibility, Design for Manufacturability, Molding.
  • You have experience with statistical analysis (e.g. using JMP, Minitab) and Design of Experiments.

Preferred

  • You have experience with Design Controls for regulatory compliance & filing (ISO 13485, etc): GDP/GLP/GMP, Design History Files, protocols/reports, hazards analyses, batch records, etc.
  • You have experience within Modeling including Monte Carlo Simulations, Tolerance Analysis, Finite Element Analysis.
  • You have a Six Sigma (Green/Black Belt) DMAIC and DFSS.

Relocation benefits are not available for this job posting.

The expected salary range for this position based on the primary location of South San Francisco, CA is $80,100 to $148,700 for the Device Engineer title, $95,900 to $178,100 for the Senior Device Engineer title. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.

Benefits

Genentech is an equal opportunity employer, and we embrace the increasingly diverse world around us. Genentech prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status.



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