1 Amgen Center Dr. Thousand Oaks, CA 91320 US
Pay range is $37 - $43 per hour with full benefits available, including paid time off, medical/dental/vision/life insurance, 401K, parental leave, and more. Our compensation reflects the cost of labor across several US geographic markets. Pay is based on several factors including market location and may vary depending on job-related knowledge, skills, and experience.
THE PROMISES WE MAKE:
At Crystal Equation, we empower people and advance technology initiatives by building trust. Your recruiter will prep you for the interview, obtain feedback, guide you through any necessary paperwork and provide everything you need for a successful start. We will serve to empower you along the way and provide the path for your professional journey.
Onsite role potentially hybrid.
Supporting the the Thousand Oaks Locations. Would be open to candidates near the Cambridge, MA facility as well.
- Minimum of 1 YOE project managing experience.
- 5-10 YOE in Engineering with background in med device, biotech, (Aero and Auto would also be considered).
- Bachelors or Masters Preferred.
- Preferred systems experience: Solid works, CAD, Smartsheet'
Top 3 Must Have Skill Sets:
- Project Management
- Technical understanding of design controls
- Device Engineering experience
- No Job hopping
Day to Day:
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 the 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.
- Create and execute to 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 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.
- 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.
- 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.