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Device Engineer Iii (Contractor)

Company

Genentech
Address , San Francisco, Ca
Employment type FULL_TIME
Salary $68.19 - $90.39 an hour
Expires 2023-07-11
Posted at 11 months ago
Job Description

The Position

Device Engineer III will be responsible for providing design, development and implementation support to project teams developing combination drug delivery devices for parenteral pharmaceutical therapeutics at Genentech.
The candidate has technical expertise in ¬¬the development and commercialization of drugdevice combination medical products, and provides technical leadership to support engineering, scientific and manufacturing activities within Genentech’s device development programs, including manual injection systems, automated injection systems, and interfaces with pre-filled syringes and cartridges.

The Device Engineer III will be assigned responsibilities to engineering areas and will initiate projects, define critical steps and resources, and develop practical and thorough solutions to complex problems.
The candidate will work with limited direction and may provide guidance and coordinate work activities of other personnel and may also supervise staff members.
The work is reviewed with a focus on long-term perspectives, as the Senior Engineer establishes his/her own work priorities and timelines.

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.
  • Regularly interface with staff and leaders in Contract Manufacturing,
  • Provide guidance and input regarding product development using structured product development process.
Product Core Teams, Pharmaceutical development, Packaging Development, Quality and Regulatory Affairs.
  • Plan and execute test-method validation projects, including developing, performing, and documenting test-method validation activities in accordance with cGMP requirements.
  • Write and execute Design Verification protocols and reports, including integrating the use of appropriate statistical tools in, and applying training materials for test methods.
  • Regularly interact with external development partners and components suppliers.

Design Control:
  • Participate in hazards analyses and design assessments and reviews.
  • Employ good document practices (GDP) when recording data, maintaining archives and drafting and reviewing documents.
  • Utilize electronic document archive system and collaborate with Document Control team to ensure document compliance with PQS standards and DHF regulations.
  • 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.

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.
  • Experience in the Pharmaceutical, Biotech or Medical Device industry is expected, with previous work on DOE, problem solving and modelling using physical rules.
  • At least 8 years of experience in the industry and/or academia (including advanced studies) after receiving their Bachelors degree.
Technical Knowledge:
Strong skills in relevant modeling, design controls and/or statistical analysis.
For example:
  • Six Sigma (Green/Black Belt): DMAIC and DFSS.
  • Engineering: Dessign controls, Electromechanical system design, System engineering, Testing fixture and procedure development, Root Cause Analysis.
  • Device Design: CAD, Rapid prototyping, GD&T, Material selection & Biocompatability, Design for Manufacturability, Molding.
  • Human Factors Evaluations: User needs research, Usability engineering and associated risk analyses.
  • 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.
  • Modeling: Monte Carlo Simulations, Tolerance Analysis, Finite Element Analysis.
Interpersonal Skills:
  • Excellent leadership skills.
  • Highly organized and detail oriented.
  • 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.

The pay rate ranges from $68.19/hr to $90.39/hr.

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.

Genentech requires all new hires to be fully vaccinated against COVID-19 as of their start date. This requirement is a condition of employment at Genentech, and it applies regardless of whether the position is located at a Genentech campus or is fully remote. If you are unable to receive the vaccine due to a disability or serious medical condition, or because it is prohibited as a result of your sincerely held religious beliefs, you will have an opportunity to request a reasonable accommodation.