Sr Systems Engineer
Sr Systems Engineer
We are looking for a Sr Systems Engineer to join our client in Bedford, MA on a direct hire basis.
The Sr. Systems Engineer will lead projects and work collaboratively with Engineers, Scientists, Quality, Management, and external partners/consultants for all stages of product development. You will create plans, requirements, designs/models, prototypes, risk analyses, design output, processes, protocols, reports, traceability analyses, and test fixtures/utilities. You will perform analyses, conduct experiments, develop designs, conduct design reviews, and implement/integrate/verify designs.
- Planning of projects/tasks throughout the product lifecycle, concept through commercialization.
- Development and design verification of complex IVD device and disposables including HW, optics, magnetics, and fluidics.
- Lead development and design transfer activities with external development and manufacturing, partners and consultants.
- Oversee product certification, e.g. CE, IEC 61000, IEC 61010, & IEC 61326.
- Ensure compliance with the Quality Management System for 21 CFR 820 & ISO 13485.
- Develop appropriate processes and procedures.
- Develop/operate test software, e.g. LabVIEW, python, and custom internal utilities.
- Help set up clinical study sites and prepare 510(k) regulatory submissions.
- BS in electrical, mechanical, or biomedical engineering. MS preferred.
- 7-10 years of systems engineering experience in a medical device/IVD company.
- Hands-on experience with programmable electro-mechanical instrument development.
- Experience creating design control documents for the DHF including plans, requirements, risk management, protocols, reports, design output, design/phase reviews, and traceability analyses.
- Experience in bringing products to market including FDA clearance/approval.
- Self-motivated and able to prioritize and organize time effectively.
- Excellent record-keeping, written and oral skills.
- Highly organized, pays attention to detail, and completes assigned tasks on time.
- Proactively communicates with supervisor and team.
- Effectively communicates across internal & external teams to ensure all requirements are met.