: Senior Engineer (JP8105)
Thousand Oaks, CA
: 12 months with likely extensions
Job posting date
Remote until COVID-19 restrictions are lifted. On site at times.
3 Key Consulting is hiring a Senior Engineer for a consulting engagement with our direct client, a leading global bio-pharmaceutical company.
- Candidate will be working remotely & on site at times at Thousand Oaks.
- 5+ years within medical device, ideally combination products: drug delivery devices and/or drug-device combination products (development, commercialization, and lifecycle management).
- Experience in technical documentation - heavy documentation supporting regulatory findings
BS in Engineering (Mechanical or Biomedical).
- This role will support project teams in the design, development, and life cycle management of drug delivery devices.
- This includes technical operations support for design control activities, technical documentation for regulatory filing, contract manufacturing, failure investigation, leading and assessing design changes, development of test procedures, scale-up, and continuous improvement.
- Scope includes mechanical and electro-mechanical delivery devices such as fluid transfer devices, automatic pen injectors, and micro-infuser delivery pump systems.
- The qualified candidate will be part of a sustaining device engineering team that ensures design history files of the mechanical and electro-mechanical delivery devices are maintained.
- The engineer will participate in cross functional teams, leading device design activities such as developing product enhancements, analytical failure analysis and implementing design solutions, assessment of proposed changes, product launches, and defending inspection and follow through of commitments.
Top Must have Skill Sets:
- Work cross-functionally with individuals and within project teams to provide technical assistance to projects.
- Develop and maintain technical records within design history file associated with assigned products.
- Develop test methods, generate and maintain design specification, protocol & report writing, prototyping, DOE/SPC product optimization, design verification & validation, FMEA, design transfer, etc.
- Support system level root cause investigation, design improvements with development partners, strategic planning and execution of design changes and improvements.
- Work with Scientists and Engineers internally and externally to assess and develop appropriate design and manufacturing specifications.
- BS in Engineering (Mechanical / Industrial / Biomedical) and previous experience in a medical device, or similar industry, with 5 - 10 years current experience with engineering processes and procedures.
- Strong background in engineering of electro-mechanical and disposable medical devices and combination products.
- Ability to model and analyze mechanical systems, fluid flow, stress, assemblies, structures, linkages, heat transfer and other mechanical engineering specialties.
- 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.
- 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.
- Familiarity with the following standards:
o 21CFR820 Quality System Regulation
o ISO 14971 Risk Management
o EU Medical Device requirements
o Medical Devices Directive 93/42/EEC
o Medical Electrical Equipment
o EN 60601
Employee Value Proposition:
- Expertise in design verification & validation, FMEA, design transfer, root cause investigation, design improvement and product optimization, etc.
- Expertise in technical documentation (protocol & report writing)
- Technical documentation for regulatory submission.
- Familiarity with EU MDR, NBO, etc.
Supports market/commercial products & pipeline products, exposure to multiple product teams.
- Non-engineering educational qualification
- No direct experience with medical devices and/or combination products
- Relevant work experience of less than 5 years
- Job hopping
Initial phone screening followed by video interviews with team.
Process will start immediately.
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.