At a Glance
- Tasks: Lead and support the development of innovative biotech combination products.
- Company: Join a leading global biotechnology company with a focus on medical devices.
- Benefits: Competitive hourly rate, flexible work options, and potential for contract extension.
- Other info: Dynamic team environment with opportunities for professional growth.
- Why this job: Make a real impact in biotech while working on cutting-edge medical devices.
- Qualifications: 5-10 years in engineering, project management experience, and a background in medical devices.
The predicted salary is between 51 - 51 $ per hour.
Location: Cambridge, MA or Thousand Oaks, CA.
Business Unit: Pre-filled Syringes and Lyo Kit Platforms
Employment Type: Contract
Duration: 18+ months (with possible extensions)
Rate: $45 - $51/hour W2
Notes: Only qualified candidates need apply. Onsite, with some WFH flexibility.
3 Key Consulting is recruiting a Senior Engineer, Combination Devices for a consulting engagement with our direct client, a leading global biotechnology company.
Ideal candidate: Minimum of 1 year of project management experience. 5-10 years in Engineering with a background in medical devices, biotech (Aero and Auto would also be considered). Bachelors or Masters preferred. Preferred systems experience: SolidWorks, CAD, Smartsheet.
Responsibilities:
- Lead and support the Prefilled syringe combination product platform team in both development and commercial lifecycle of prefilled syringe (PFS) configurations.
- Experience leading and managing project timelines and initiatives while reporting out to management.
- Scope includes a full range of PFS devices and variants, such as needle protection systems and different delivery volumes.
- Lead technical teams to ensure successful device development of these mechanical devices.
- Work closely with team members acting as a project manager to develop detailed timelines for ensuring engineering specifications, device design & development, verification, validation, and regulatory submissions of these devices are completed on time.
Top Must Have Skill Sets: Project Management; Technical understanding of design controls; Device Engineering experience.
Day to Day Responsibilities:
- Support platform and product development teams by acting as a project manager to ensure timelines and delivery dates are met.
- Provide technical support and insights to team members and lead platform initiative projects.
- Create and execute project plans and schedules; responsible for ensuring team meets project timelines.
- Work cross-functionally with Marketing, Operations, and Development teams.
- Create and assess product requirements to determine technical coverage and proper integration of different subsystems.
- Support development, execution, and review of design documents, specifications, development plans, characterization plan, verification and validation plans and other related product development documents for assigned projects.
- Provide deep technical assistance for junior engineers.
Basic Qualifications:
- BS in Engineering and previous experience in a medical device industry.
- 5-10 years current experience with engineering processes and procedures.
- Project Management experience.
- Strong background in engineering and commercialization of 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.
- Experience in drug/device combination product design and development.
- Strong problem solving, risk assessment, and risk management skills.
- Must be capable of working on multiple projects in a deadline driven environment.
Interview Process: Initial phone screenings and then Webex interviews with a panel of 3-6 team members. Series of 1:1 interviews.
Application: We invite qualified candidates to send your resume. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.
Senior Engineer, Biotech Combination Products employer: 3key Consulting, Inc.
Join a leading global biotechnology company in Cambridge, MA or Thousand Oaks, CA, where innovation meets collaboration. As a Senior Engineer, you'll thrive in a supportive work culture that values employee growth and offers flexible work-from-home options. With a focus on meaningful projects in the medical device sector, you'll have the opportunity to lead technical teams and drive impactful product development while enjoying competitive compensation and a commitment to professional development.
