Device Engineer (H)

Device Engineer ROCGJP00020650 (H) A leading biotechnology company is looking for a Device Engineer.

The successful candidate will be responsible for providing design, development, and implementation support to project teams developing combination drug delivery devices for parenteral pharmaceutical therapeutics at our company.

The ideal candidate has technical expertise in the development and commercialization of drug-device 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.

Device Engineer Pay and Benefits: Hourly pay: $75-$85/hr Worksite: Leading biotechnology company (South San Francisco, CA 94080) W2 Employment, Group Medical, Dental, Vision, Life, PSL 40 hours/week, 12 Month Assignment Device Engineer Responsibilities: Responsible for supporting activities within the 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 a 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.

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.

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 hazard analyses and design assessments and reviews.

Utilize electronic document archive system and collaborate with the Document Control team to ensure document compliance with PQS standards and DHF regulations.

Device Engineer Qualifications: 8 years of experience in the industry and/or academia (including advanced studies) after receiving a Bachelor’s degree.

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 modeling using physical rules.

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

For example: Engineering: Design controls, Electromechanical system design, System engineering, Testing fixture and procedure development, Root Cause Analysis.

Modeling: Monte Carlo Simulations, Tolerance Analysis, Finite Element Analysis.

Device Design: CAD, Rapid prototyping, GD&T, Material selection & Biocompatibility, 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.

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