Senior Engineer, Devices and Combination Products
The Senior Engineer has global responsibility for providing reliable, safe, and efficient products. This role will interact across functional groups and geographical regions. The Senior Engineer is the key point of contact for device manufacturing process topics including devices usability, combination product requirements, commercial specifications, design history files, and change control process. Key Responsibilities:
- Have in-depth Devices & Combination product knowledge and provide the technical leadership to guide the new products design
- Support post approval regulatory submission for market expansion and timely technical responses to FDA and global healthcare authority inquiries.
- Lead device design transfer, maintain Design History Files, and manage post approval device changes.
- Collaborate with R&D to develop drug delivery devices for pipeline products.
- Assess new and existing ISO standards for medical devices and combination products to ensure regulatory compliance and maintain license to operate.
- Engage cross-functional teams to gather and incorporate inputs for managing on-market product changes.
- Use statistical analysis to evaluate raw data acquired through verification and validation study results.
- A Master's Degree in Engineering Physics and /or Biomedical Engineering, plus demonstrated competence.
- Competency with design control and technology transfer processes.
- Experiences in devices testing and issue investigation for root cause analysis.
- Design skills with microprocessors, digital logic, BOM maintenance, FMEA and firmware.
- Knowledge of multiple Schematic Capture and PCB Layout tools including Cadence and Altium electronic design software.
- Strong analytical, decision making and communication skills
- Ability to create and manage project schedules and help identify project risks
- Listens to and understands others' points of view.
- Works well with other engineers in a collaborative, fast-paced goal-driven environment.
- Capacity and willingness to learn and grow in science and technology fields.
Equal Opportunity Employer Minorities/Women/Veterans/Disabled