Senior Engineer, Device Development

United States of America, California, South San Francisco

de fr es ru tr it pt zh ja

Job Responsibilities

The incumbent in this position will be responsible for supporting activities within Device Development department and facilitating product development towards the goal of commercialization.  This objective will be accomplished by executing activities in the areas of:

Device Engineering:

  • Develop and commercialize devices including interfaces with the primary container.
  • Provide guidance and input regarding product development.
  • Regularly interface with staff and leaders in Commercial Marketing, Clinical Sciences, Contract Manufacturing,

Product Core Teams, Pharmaceutical development, Packaging Development, Quality and Regulatory Affairs.

  • Regularly interact with external development partners and components suppliers.
  • Plan and execute test-method validation projects, including developing, performing, and documenting test-method validation activities in accordance with cGMP requirements.
  • Write and execute protocols and reports, including integrating the use of appropriate statistical tools in validation protocols, and applying training materials for test methods.
  • Generate/execute equipment qualification (IQ, OQ, PQ) protocols, provide input, and execute plans to ensure robust equipment operation and data management, and direct others in the execution of protocols.

Quality Systems Compliance:

  • Understand, implement and maintain Roche Pharma Quality Policy and Pharma Quality System (PQS) in the department.
  • Use (and create and implement, if necessary) local PTDU-D procedures and templates ensuring alignment with current versions of PQS documents and best practices.
  • Assist with resolving issues arisen from internal quality assessments/audits, regulatory inspections and notified body interactions, and aid in driving closure of inspection issues by preparing appropriate responses and corrective action resolutions.
  • Create and review discrepancy, change and risk management documents for PTDU-D and Devices Teams, as appropriate.
  • Ensure compliance of training to PQS and job-related requirements.

Design Control:

  • Draft, review and/or approve design control documents (i.e. DHF documents) to support device development deliverables using available templates, such as protocols and reports, design verification, design validation, failure modes effects and analysis, risk management plans, change management plans and design review meeting minutes.
  • Employ good document practices (GDP) when recording data, maintaining archives and drafting and reviewing documents.
  • Participate in hazards analyses and design assessments and reviews.
  • Utilize electronic document archive system and collaborate with Document Control team to ensure document compliance with PQS standards and DHF regulations.

Qualifications

Education and Industry Experience:

  • B.S, M.S, Ph.D or advanced degree in Engineering, with preferences for Mechanical Engineering, Materials Science Engineering Electrical Engineering, Chemical Engineering, or the equivalent.
  • At least 8 years of experience in the industry and/or academia (including advanced studies) after receiving their Bachelors degree.
  • Experience in the Pharmaceutical, Biotech or Medical Device industry is expected, with previous work on DOE, problem solving and modelling using physical rules.

Technical Knowledge:

Strong skills in relevant modeling, design controls and/or statistical analysis.

For example:

  • Engineering: Electromechanical system design, System engineering, Process/Industrial Engineering, Injection molding and Mold-Flow analyses.
  • Modeling: Monte Carlo Simulations, Tolerance Analysis, Finite Element Analysis.
  • Device Design: CAD, Rapid prototyping, GD&T, Material selection & Biocompatability, Design for Manufacturability, Molding.
  • Full data and statistical analysis (JMP, Minitab) and Design of Experiments.
  • Design Controls for regulatory compliance & filing (ISO 13485, etc): GDP/GLP/GMP, Design History Files, protocols/reports, hazards analyses, batch records, etc.
  • Six Sigma (Green/Black Belt): DMAIC and DFSS.
  • Human Factors Evaluations: User needs research, Usability engineering and associated risk analyses.

Interpersonal Skills:

  • Proven track record of working effectively in a matrix organization with a highly cross-functional (e.g., device development, regulatory, clinical, quality, and program management) and collaborative environment is very desirable.
  • Excellent communication skills are required.  Experience in working with external partners is also highly desirable.
  • Highly organized and detail oriented.
  • Excellent leadership skills.

#LI-CGDL1