Staff Engineer – Medical Devices (Design & Validation)

Sirtex; Boston (MA); Hybride; USD 130 000 - 157 000; Plein temps

Avantages offerts par ce poste

Health insurance

401(k) matching program

Paid vacation and sick leave

Diversity and professional growth

Résumé du poste

Sirtex Medical is seeking a senior engineer to drive the design and development of next‑generation medical devices in a hybrid Boston office. The role encompasses prototyping, verification, validation testing, data analysis, and root-cause investigations to ensure compliant, innovative products for oncology therapies.

The candidate will lead cross‑functional teams across engineering, regulatory, manufacturing, and marketing, coordinating design control activities and documentation for regulatory

Qualifications

• Bachelor’s degree in Mechanical or Biomedical Engineering with 10+ years in industry.
• Master’s degree preferred in Mechanical or Biomedical Engineering.
• Experience in the design of Class II and Class III medical devices or combination products.
• Experience working in a broader enterprise/cross-division model.
• Experience designing mechanical and electro-mechanical devices.
• Project leadership and management skills.

Responsabilités

• Design and develop new products using multidisciplinary engineering knowledge.
• Support regulatory, manufacturing, marketing, and sales in product research and design.
• Plan, schedule and coordinate project tasks and activities.
• Conceive and build working prototypes and perform testing and analysis.
• Collaborate with outside consultants, suppliers, and clinicians.
• Prepare documentation including risk analyses and verification protocols.

Connaissances

Project leadership

Mechanical design

Cross-functional collaboration

Formation

Bachelors in Mechanical or Biomedical Eng

Masters degree preferred

Description du poste

Sirtex Medical is seeking a senior engineer to drive the design and development of next‑generation medical devices in a hybrid Boston office. The role encompasses prototyping, verification, validation testing, data analysis, and root-cause investigations to ensure compliant, innovative products for oncology therapies.

The candidate will lead cross‑functional teams across engineering, regulatory, manufacturing, and marketing, coordinating design control activities and documentation for regulatory