: Senior Engineer (JP8620)
Thousand Oaks, CA or REMOTE
: 12 months with likely extensions
Job posting date
Remote until COVID-19 restrictions are lifted.
3 Key Consulting is hiring a Senior Engineer for a consulting engagement with our direct client, a leading global bio-pharmaceutical company.
Top Must have Skill Sets:
- Candidate has option to be fully remote, must work PST. Ideal candidate will be local to ATO location.
- VERY IMPORTANT NOTE: Qualified candidates with either a strong Electrical Engineering, Mechanical Engineering, OR Systems/Software Engineering background will be considered.
- 5+ years of quality and manufacturing experience in biotech or pharmaceutical industry (Design Control, Human Factors, dFMEA, pFMEA, Device or Combo Product)
- Familiar with final products including applicable guidance, regulations, and standards (e.g., MDR, ISO 14971, ICH Q9, ICH Q8, ICH Q10, ISO 13485, EU Annex 1, 21 CFR parts 4, 820, 210 and 211)
- Ability to oversee multiple medium complexity projects simultaneously.
- Human factors, risk management, software experience.
- Lead teams in the development of drug delivery devices.
- Scope includes a wide range of devices, such as needle protection systems, fluid transfer devices, pen injectors, automatic pen injectors, and micro-infuser delivery pump systems.
- The qualified candidate will lead technical teams to ensure successful device development of these mechanical and electro-mechanical medical devices.
- The Principal Engineer will work closely with team members to develop detailed engineering specifications, device design & development, support verification, validation, and regulatory submissions of these devices.
- The role of the Principal Engineer is to work within a cross-functional organization to utilize technologies and methodologies that support short-cycle robust device development.
- Work cross-functionally with individuals and project teams in Marketing, Operations, and Development.
- Create and assess product requirements to determine technical coverage and proper integration different subsystems.
- Create and execute to project plans and schedules.
- Develop, execute, and review architecture documents, design documents, specifications, development plans, characterization plan, verification and validation plan and other related product development documents for assigned projects.
- Provide deep technical assistance for junior engineers.
- Skills: - BS in Engineering and previous experience in a medical device industry.
- 5+ years current experience with engineering processes and procedures.
- Led projects from development through the 510k and PMA approval process.
- Strong background in engineering and commercialization of electro-mechanical medical devices.
- Experience with material & test specs generation, protocol & report writing, process & test development, prototyping, design verification, DOE/SPC process optimization & validation (IQ, OQ, PQ), FMEA.
- Product design/development (design control) from concept to post product launch for Europe (EMEA/CE Mark) & US (FDA/PMA/510k) submissions.
- Experience in drug/device combination product design and development.
- Familiar with the following standards:
- Quality System Regulation 21CFR820
- Risk Management
- ISO 14971
- EU Medical Device requirements
- Council Directive 93/42/EEC
- Medical Electrical Equipment
- EN 60601.
- Small scale device assembly experience.
- Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.
- Strong problem solving, risk assessment, and risk management skills.
- Must be capable of working on multiple projects in a deadline driven environment.
- Provide Quality technical expertise, Quality oversight, and a single point of Quality contact for combination and non-combination products associated with Final Product Technologies activities.
- Attend development program meetings as required as part of program working teams.
- Work cross-functionally with individuals and project teams to ensure success of development project efforts.
- Provide guidance on documentation structures created during development activities.
- Responsible for identifying proper GMP or Non-GMP phase-appropriate documentation strategies and repositories required for the design and development process to ensure compliance with applicable regulations and the client Procedures.
- Provide input to the Design and Development Plans for projects, and review and approve relevant final product Design Control documentation including (Design Input Documents, Risk Summary Reports, Verification Plans, Characterization Protocols and Reports, Design Validation/Qualification Protocols and Reports, Design Specifications, Trace Matrices, Design and Tech Transfer Plans, PLAN Specifications (Development), PCS device configuration specifications (qualified), PLAN component specifications (developmental), PCS component specifications (qualified), Create the Design Traceability Matrix, and provided review and approval for subordinate project plans and associated projects.
- Actively participate and contribute to applicable Design Control Phase Design Reviews.
- Also provide Quality oversight of Design Characterization and Verification and Validation activities. Ensure adherence to all relevant regulations and standards based on the type of device under development.
- Represent FPTQ Development Quality and participate in onsite supplier due diligence visits, as needed, in support of supplier qualification and development as it relates to design control activities.
- Contribute to content and review of regulatory submissions and RTQs by collaborating to develop complete formal written responses.
- Participates in audits and inspections, is well prepared by owning relevant details that are supported by evidence for associated projects.
- Scope may include a wide range of devices, including but not limited to prefilled syringes, needle protection systems, fluid transfer devices, pen injectors, automatic pen injectors, and on-body injector systems.
- Development projects may include primary container, mechanical, electrical, and/or software as part of the system(s).
- Responsible for ensuring program alignment and proper linkages within the Design and Development Plans, Risk Management Documentation, and Control Plans Provide oversight and review of Human Factors Engineering (HFE) Protocols and Reports, as well as onboarding and auditing HFE suppliers.
- Doctorate degree OR
- Master’s degree and 3 years of Quality experience OR
- Bachelor’s degree and 5 years of Quality experience
- 5+ years of quality and manufacturing experience in biotech or pharmaceutical industry (device experience a plus)
- Bachelor’s Degree in a Science Field
- Ability to oversee multiple medium complexity projects simultaneously.
- Working knowledge of quality engineering and/or mechanical engineering
- Familiar with final products including applicable guidance, regulations and standards (e.g., MDR, ISO 14971, ICH Q9, ICH Q8, ICH Q10, ISO 13485, EU Annex 1, 21 CFR parts 4, 820, 210 and 211)
- Prior experience working as part of a combination product launch team.
- Able to successfully manage workload to timelines.
- Ability to effectively negotiate, articulate, and defend a position after taking feedback from multiple sources.
- Ability to operate in a matrixed or team environment with site, functional, and executive leadership.
- Experience driving decision making by using DAI principles.
- Understanding of industry requirements/expectations of a QMS
- Understanding of the applicable manufacturing/testing processes (i.e. API, Drug Substance, Drug Product, Packaging, Device manufacturing processes) Execution of technical standards, internal requirements, and regulations
- Comfortable with both drug and device terminology
- Ability to travel +/- 15-20% of time to domestic and international client sites
- Deep and broad understanding of quality processes including change control, design controls, risk assessment and management, and root cause analysis.
- Combination product knowledge and understanding including functional knowledge of applicable guidance, regulations and standards to enable future compliance as projects enter design controls
- Knowledge of quality engineering and device engineering
- Demonstrated ability to analyze data, including knowledge and proficiency with basic statistics
- Strong problem solving, trouble shooting, and analytical skills
- Advanced technical writing skills
- Able to balance complexity between innovation and regulation
- Ability to work effectively in global cross-functional teams and in a highly matrixed team environment
- Constructively progress to outcomes despite uncertainty or ambiguity
- Drive change, efficiency, and strong cross-functional relationships
- Excellent verbal and written communication
- Lead and motivate a team
- Ability to drive continuous improvements
- Technical writing
- Critical thinking
- Global mindset
- Situational analysis and reporting
- Process improvement focus(CI / Lean)
- Solution identification
Employee Value Proposition:
- Provides Quality oversight to final product development activities and deliverables (A)
- Quality approval of project related design control documents (D)
- Quality approver and/or author for Quality Plan (D)
- Advises PDT and/or technical team in collaboration with PQL on level of risk for phase specific development activities (A)
Opportunity to work in design control space, exposure to development of the delivery systems that client drug product is delivered through
Lack of must have skills, jumpy job history.
Phone screen & Video conference
We invite qualified candidates to send your resume to firstname.lastname@example.org. If you decide that you’re not interested in pursuing this position, please feel free to look at other positions on our website www.3keyconsulting.com
. You are welcome to also share this posting with anyone you think might be interested in applying for this role.