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Device Engineer III

South San Francisco, CA 94080

Posted: 09/18/2023 Employment Type: Contract Job Category: Engineering Job Number: 579184 Is job remote?: No Country: United States

Job Description


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.

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 our device development programs, including manual injection systems, automated injection systems, and interfaces with pre-filled syringes and cartridges. The Senior Device Engineer 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.
  • Provide guidance and input regarding product development using structured product development process.
  • Regularly interface with staff and leaders in 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 Design Verification protocols and reports, including integrating the use of appropriate statistical tools in, and applying training materials for test methods.

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.



Pay Rate Range: $70-90/hr. Salary will be commensurate with experience 

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma and The Planet Group of Companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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About South San Francisco, CA

Ready to take the next step in your career journey? Explore our job opportunities in the vibrant area surrounding South San Francisco, California! Known for its proximity to the iconic Golden Gate Bridge and the bustling tech hub of Silicon Valley, this region offers unrivaled growth potential and a dynamic work environment. With a unique blend of culture, including the renowned SFMOMA art museum, the lively Castro District, and delectable cuisine like the famous sourdough bread at Boudin Bakery, South San Francisco is the perfect place to thrive professionally while enjoying the beauty of nearby parks like Golden Gate Park and the breathtaking views of the Pacific Ocean. Join us in discovering the endless possibilities for your career in this enchanting region!

Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.