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.
Job Description:
Ideal candidate:
- Minimum of 1 year of project managing 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.
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. The qualified candidate will lead technical teams to ensure successful device development of these mechanical devices. The Senior Engineer will 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:
- Supporting platform and product development teams by acting as a project manager to ensure timelines and delivery dates are met.
- Providing technical support and insights to team members and leading platform initiative projects.
- Create and execute project plans and schedules; responsible for ensuring team meets project timelines.
- 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 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.
Preferred Qualifications:
Why is the Position Open? Supplement additional workload on team.
Red Flags:
No Job hopping.
Interview Process:
Initial Phone screenings and then Webex interviews with a panel of 3-6 team members. Series of 1:1 interviews.
We invite qualified candidates to send your resume to resumes@3keyconsulting.com. 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.
Regards, 3KC Talent Acquisition Team
Senior Engineer, Biotech Combination Products (JP11782C) in Cambridge employer: 3 Key Consulting
3 Key Consulting is an exceptional employer located in the vibrant biotechnology hub of Cambridge, MA, offering a unique opportunity for engineers to gain valuable biopharma experience. With a strong emphasis on employee growth and development, the company fosters a collaborative work culture that encourages proactive troubleshooting and continuous improvement. Employees benefit from engaging projects, hands-on experience with cutting-edge technology, and a supportive environment that values innovation and teamwork.
StudySmarter Expert Advice🤫
We think this is how you could land Senior Engineer, Biotech Combination Products (JP11782C) in Cambridge
✨Tip Number 1
Network like a pro! Reach out to your connections in the biotech and engineering fields. Attend industry events or webinars, and don’t be shy about introducing yourself. You never know who might have the inside scoop on job openings or can put in a good word for you.
✨Tip Number 2
Prepare for those interviews! Research the company and its products thoroughly. Be ready to discuss how your experience aligns with their needs, especially in project management and device engineering. Practise common interview questions and have your own questions ready to show your interest.
✨Tip Number 3
Showcase your skills! Create a portfolio that highlights your engineering projects, especially those related to medical devices. Include any relevant documentation, like design specs or project plans, to demonstrate your expertise and problem-solving abilities.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen by the right people. Plus, keep an eye on our careers page for new opportunities that match your skills and interests.
How to prepare for a job interview at 3 Key Consulting
✨Know Your Stuff
Make sure you brush up on your technical knowledge related to medical devices and biotech. Familiarise yourself with design controls, project management principles, and the specifics of prefilled syringe configurations. This will help you answer questions confidently and demonstrate your expertise.
✨Showcase Your Project Management Skills
Prepare examples from your past experiences where you've successfully managed projects. Highlight how you created timelines, coordinated with cross-functional teams, and ensured that deliverables were met. This will show that you can handle the responsibilities of the Senior Engineer role effectively.
✨Ask Insightful Questions
During the interview, don’t hesitate to ask questions about the team dynamics, project challenges, and the company’s approach to product development. This not only shows your interest but also helps you gauge if the company culture aligns with your values.
✨Be Ready for Technical Challenges
Expect some technical questions or case studies during the interview. Prepare to discuss your problem-solving strategies and how you would approach specific engineering challenges related to combination products. This will demonstrate your critical thinking and technical prowess.
