Lead Staff Engineer, Medical Device Development

Sirtex Medical Limited; Woburn (MA); Hybrid; USD 124,000 - 155,000; Full time

Benefits offered by this job

Medical, dental, vision and life 보험

401(k) matching

Paid vacation and sick leave

Job summary

Sirtex Medical is seeking a Staff Product Development Engineer to serve as the senior technical authority across design controls, verification, validation and regulatory submissions from concept through commercialization. This hands-on leadership role sets technical direction for cross-functional teams, owns critical documentation, and mentors engineers who will grow into technical leads.

Responsibilities include leading design transfers, process validation, and FDA/EU submissions, while

Qualifications

• 10+ years of medical device product development in Class II/III PMA devices.
• Hands-on authoring of verification, validation and process validation reports.
• Familiar with 21 CFR 820 / QMSR, ISO 13485, ISO 14971 and ISO 10993.
• Able to explain risk and trade-offs to leadership and non-engineers.
• Experience leading FDA PMA/IDE/510(k) submissions and audits.

Responsibilities

• Lead one or more development programs from needs to commercial launch.
• Collaborate with Quality, Manufacturing, Regulatory and Marketing.
• Own Design History File content and drive design reviews with traceability.
• Lead FDA/EU submissions and engage with regulators as needed.
• Mentor engineers and improve engineering efficiency.

Skills

Design controls

Regulatory submissions

Design Verification

Process Validation (IQ/OQ/PQ)

Statistical analysis

Risk management (ISO 14971)

Leadership/mentoring

FDA PMA/IDE/510(k) submissions

Root cause investigations

HF/E guidance familiarity

Six Sigma training

Education

Bachelor's degree in Biomedical/Mechanical engineering

Master's degree (MS) in engineering

Tools

SolidWorks

Minitab

JMP

Job description

Sirtex Medical is seeking a Staff Product Development Engineer to serve as the senior technical authority across design controls, verification, validation and regulatory submissions from concept through commercialization. This hands-on leadership role sets technical direction for cross-functional teams, owns critical documentation, and mentors engineers who will grow into technical leads.

Responsibilities include leading design transfers, process validation, and FDA/EU submissions, while