Senior Device Engineer - Device Development
San Francisco, CA
- Posted: over a month ago
Senior Device Engineer - Device Development
The Senior Device Engineer 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 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 the company's 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.
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:
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 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 Design Verification protocols and reports, including integrating the use of appropriate statistical tools in, and applying training materials for test methods.
Understanding of equipment qualification (IQ, OQ, PQ) protocols. Ability to 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 the company's 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.
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.
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.
Strong skills in relevant modeling, design controls and/or statistical analysis.
Engineering: Electromechanical system design, System engineering, Process/Industrial Engineering, Injection molding and Mold-Flow analyses.
Modeling: Monte Carlo Simulations, Tolerance Analysis, Finite Element Analysis.
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.
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.
Security Clearance Required: No
Visa Candidate Considered: No
AddressSan Francisco, CA
EngineeringView all jobs at Resiliency LLC