Massachusetts Green Jobs

Principal Medical Device Systems Engineer

Marlborough, MA

Job Type: Contract

Recruiter: Jaime Gunning (https://digitalprospectors.com/our-team/jaime-gunning)

Phone: 617.215.7066

Position: Principal Medical Device Systems Engineer

Location: Marlborough, MA (Hybrid – 2 to 3 days onsite)

Length: 6-12 months

Job Description:

Our client is looking for a Principal Medical Device Systems Engineer who will lead cross-functional teams in defining, architecting, and implementing projects related to aesthetic laser systems and accessories. The Principal Medical Device Systems Engineer will collaborate with various departments, oversee the development of new accessories, upgrades to existing laser systems, and the creation of new systems. The Principal Medical Device Systems Engineer will translate product requirements into design specifications, managing system engineering activities in an FDA regulated environment, and ensuring compliance with quality standards for medical devices.

Essential Duties and Responsibilities (but not limited to):

• Lead system engineering activities in an FDA regulated environment, adhering to quality requirements and regulatory standards for medical devices.

• Utilize systems engineering methodologies to define system requirements and manage them throughout the product lifecycle.

• Collaborate with internal and external partners to develop design concepts and feasibility studies.

• Represent systems engineering and research and development on cross-functional teams, managing program and technical risks.

• Assist in creating technical project schedules and tracking progress.

• Evaluate design tradeoffs and manage technical risks while balancing cost, schedule, and performance.

• Collaborate with functional leads to develop detailed design specifications and support engineering activities.

• Lead technical product risk assessment activities and define engineering and system integration plans.

• Work with System V&V and Engineering Test leads to establish test strategies and ensure compliance with regulatory requirements.

• Conduct failure analysis and troubleshooting activities throughout the product lifecycle.

• Participate in design reviews and technical reviews of subsystems.

• Drive collaboration among cross-functional partners to ensure product designs meet requirements and operational goals.

Qualifications:

• Bachelor's degree in Electrical, Mechanical, Biomedical, or Systems Engineering (Master's degree is preferred).

• 8+ years of post-undergraduate work experience in designing complex medical systems in a regulated environment.

• Working knowledge of FDA, EU, IEC, AAMI, and ANSI standards related to medical devices.

• Experience creating DHF and technical file deliverables, including system requirements and risk analyses.

• Proficiency with RTM tools and Microsoft Office tools.

• Excellent interpersonal, organizational, verbal, and written communication skills.

• Project management experience, including managing multiple projects.

• Familiarity with optical modeling, fluid dynamics, heat transfer, MATLAB, Minitab, OrCAD, and SolidWorks is a plus.

POST-OFFER BACKGROUND CHECK IS REQUIRED. Digital Prospectors is an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other characteristic protected by law. Digital Prospectors affirms the right of all individuals to equal opportunity and prohibits any form of discrimination or harassment.

Make this your next career move as one of our many long-term contractors or employees!

• Work as our full-time employee with full benefits (Medical, Dental, Vision, Life, STD, LTD, PTO, etc.) - OR - work as a W2 hourly contractor at a higher pay rate if you don't need the benefit package.

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• 4.9/5 Star Glassdoor rating and the only staffing company (< 1000 employees) to be voted in the national Top 10 ‘Employee’s Choice - Best Places to Work’ by Glassdoor.

• Voted ‘Best Staffing Firm to Temp/Contract For’ six times by Staffing Industry Analysts as well as a ‘Best Company to Work For’ by Forbes, Fortune and Inc. magazine.

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