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Production Engineer II
Pilatus Aircraft USA Ltd
Broomfield, CO
Pilatus is hiring a Production Engineer to join our team in Broomfield, CO. In this role, you will use your extensive production, manufacturing and engineering experience to translate…
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Senior Manufacturing Engineer
Toyon
Goleta, CA
- $130,000 to $200,000 USD / year
…national security applications. We’re seeking a Manufacturing Engineer to help build next-generation RF sensors for some of the world’s most advanced military…
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Staff Process Engineer, Drive Unit (3rd Shift)
Rivian
Normal, IL
Rivian is seeking a highly motivated and skilled Staff Process Engineer to optimize our manufacturing processes and uphold the highest standards of product quality. The ideal candidate will…
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Sr. Process Engineer, Drive Unit (3rd Shift)
Rivian
Normal, IL
Rivian is looking for Senior Process Engineers to improve the production output in Normal, IL. As a Senior Process Engineer, you will have the opportunity to plan utilization of…
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Staff Interior Trim Design & Release Engineer
Rivian
Irvine, CA
Rivian seeks a Staff Design & Release Engineer to conduct development and end-to-end
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Senior Specialist, Data Engineer
Planned Parenthood Federation of America
NY · Washington, DC
- $90,000 to $95,000 USD / year
…(PPAF) seek a conscientious and collaborative Manager, Data Engineer. This job reports to the Director, Data Architecture in the Data Architecture & Governance department within the…
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Manufacturing Engineer
ARCH
Huntingdon Valley, PA
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Manufacturing Engineer
Actalent
Anoka, MN
Job Title: Manufacturing EngineerJob DescriptionThis Manufacturing Engineer role leads end-to-end manufacturing projects, driving process improvements, capital equipment implementations,…
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Entry Level Engineer
Actalent
Palm Beach Gardens, FL
- $30 to $33 USD / hour
adjustment of the job application process or interviewing process due to a disability,
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Propulsion Engineer
Actalent
Hampton, VA
- $57.69 to $76.92 USD / hour
Job Title: Propulsion EngineerJob DescriptionThe Propulsion Engineer designs, tunes, and validates real-time propulsion models for a wide range of aircraft engines, including turbofan,…
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Mechanical Engineer
Actalent
Newport News, VA
- $50 to $60 USD / hour
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Mission Planning Systems Engineer
Actalent
Dahlgren, VA
- $85,000 to $155,000 USD / year
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Systems Requirements Engineer
Actalent
Rockville, MD
- $45 to $65 USD / hour
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Fire Control Technician
Actalent
Manassas, VA
- $35 to $45 USD / hour
Job Title: Fire Control Technician / Hardware Engineer Submarine Training SystemsJob DescriptionThis role combines fire control test subject matter expertise with hands-on hardware…
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Systems Engineer
Actalent
Manassas, VA
- $36 to $48 USD / hour
Job Title: Systems Engineer Model Based Systems Engineering (MBSE)Job DescriptionThis Systems Engineer role focuses on Model Based Systems Engineering (MBSE) for a Tactical Control System…
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Software Engineer
Actalent
Manassas, VA
- $36 to $40 USD / hour
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C++ Software Engineer
Actalent
Manassas, VA
- $60 to $90 USD / hour
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Senior Software Engineer
Actalent
Manassas, VA
- $55 to $75 USD / hour
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Mechanical Engineer
Actalent
Bedford, OH
Collaborate with electrical, manufacturing, and project engineering teams throughout the product development process.
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Continuous Improvement Engineer
Actalent
Bedford, OH
- $48 to $58 USD / hour
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Continuous Improvement Engineer
Actalent
Akron, OH
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Manufacturing Sales Engineer
Actalent
Cudahy, WI
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Process Engineer
Actalent
Madison, WI
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3+ years of experience working as a Process Engineer or Manufacturing Engineer.
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Transmission Line Engineer
Actalent
Austin, TX
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Senior Services Sales Executive, Strategic Accounts - Americas Wes
Elastic
CO
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Sirtex

Principal Product Development Engineer

Woburn, MA, United States

$150,553 to $175,000 USD / year

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Job details

Pay: $150,553 to $175,000 USD / year
Experience: BS degree in Biomedical, Mechanical or a related engineering discipline with 12+ years of medical device product development experience, or a MS with 10+ years.
Posting language: English
Posted: Nov 6, 2026

Original job description

Company Description Sirtex Medical is a global leader in healthcare, with offices in the U.S., Australia, Germany, and Singapore, dedicated to improving patient outcomes. Our mission is to be at the forefront of minimally invasive cancer and embolization therapies. By partnering with physicians, we aim to provide innovative products that enhance patient outcomes and simplify treatments. Achieving this ambitious goal requires passionate and talented individuals who are committed to making a difference. Our flagship product, SIR-Spheres® Y-90 resin microspheres, is a targeted radiation therapy for liver cancer. To date, we have delivered over >150K doses across 50+ countries, significantly impacting patients' lives worldwide. Our success is fueled by our dedication to serving the medical community, maintaining professionalism, fostering a collaborative work culture, nurturing an entrepreneurial spirit, and continuously pursuing innovation and improvement. At Sirtex, we are committed to creating a great workplace. We offer a range of benefits, programs, and services to support our employees, ensuring they have opportunities to contribute to our success and advance their careers. Join our inclusive community, where you can collaborate with talented colleagues, bring your ideas to life, and advance your career, all while delivering innovative healthcare solutions to patients.

Job Description

About the role Sirtex Medical is hiring a Principal Product Development Engineer to serve as the senior individual-contributor technical authority. You will provide project leadership, own the technical integrity of design controls, verification, validation and regulatory submissions from concept through commercialization and sustaining. This is a hands-on leadership role. You will set technical direction for cross-functional teams, write and defend the evidence that gets products approved and keeps them on the market, and mentor engineers who will grow into the next generation of technical leads. Candidates must be local to the Boston, MA area and be willing to adhere to our hybrid work arrangements, currently 3 days/week in office and 2 days/week remote. Location: Woburn, MA - hybrid/on-site

Key responsibilities

Serve as project lead on one or more concurrent development programs, from user needs and design inputs through design transfer and commercial launch
Collaborate closely with Quality, Manufacturing, Regulatory and Marketing
Own Design History File content and lead formal design reviews, ensuring traceability from user needs to verification and validation evidence
Drive concept generation and feasibility work and protect resulting innovations through invention disclosures and patent filings
Engage marketing team and clinicians to define user needs and translate them into testable requirements
Lead and own Design Verification
Work in partnership with manufacturing and design quality to support transfer to manufacturing / Process Validation (IQ/OQ/PQ)
Manage external labs for testing including testing plan development, reports and assess the impact of design, material and supplier changes
Act as a subject matter expert for biological safety and provide strategy
Lead R&D modules of FDA submissions (PMA, PMA supplements, IDE, 510(k)) and EU MDR Technical Documentation, and respond to Regulatory and Notified Body questions
Partner with Quality on design risk management per ISO 14971, owning the engineering inputs to DFMEA/PFMEA and benefit-risk analysis
Participate in complaint investigations, root cause analysis and CAPA, and support FDA inspections and audits when needed
Partner with Quality and Manufacturing on product and process improvements
Mentor and develop engineers, including technical reviews of their protocols, reports and design decisions
Champion continuous improvement in engineering efficiency

Qualifications

BS degree in Biomedical, Mechanical or a related engineering discipline with 12+ years of medical device product development experience, or a MS with 10+ years.
Demonstrated technical leadership of Class II and/or Class III PMA devices through design controls, design transfer and commercial launch required
Hands-on authorship of Design Verification, Test Method Validation and Process Validation (IQ/OQ/PQ) protocols and reports
Working command of 21 CFR 820 / QMSR, ISO 13485, ISO 14971 and ISO 10993
Clear, concise technical writing, and the ability to explain risk and trade-offs to executive leadership and non-engineering audiences
Experience in leading the R&D module in FDA PMA, IDE or 510(k) submissions
Experience leading root cause investigations, complaint handling and CAPA
Basic proficiency with 3D CAD tools (e.g., SolidWorks) and statistical analysis tools (e.g., Minitab, JMP) required
Hands-on experience with IEC 62366-1 and FDA HFE guidance including use-related risk analysis, formative studies, critical task identification, and summative (HF validation) testing and reporting will be a plus
Formal training in statistical problem-solving (such as Six Sigma) preferred
Track record managing or mentoring engineers, co-ops or interns
Experience in a growth-stage or startup environment, where wearing multiple hats was the norm

The target anticipated annual base salary range and target bonus opportunity is $150,553 to $175,000 annually, plus a 15% target annual bonus of 15% The final position level and compensation will be determined based on non-discriminatory, job-related factors, including geographic location, skills, experience, education, and alignment with the position requirements. In addition to base salary and bonus eligibility, Sirtex offers a comprehensive benefits package, including paid sick and vacation time, medical, dental, vision and life insurance, and a generous 401(k) matching program and other benefits, subject to applicable plan terms and eligibility requirements. Additional Information All your information will be kept confidential according to EEO guidelines

Do you want to be part of something bigger? A team whose impact stretches across the globe making a real difference to the quality of people’s lives. Sirtex recognizes that well-being, financial health, and work-life balance are crucial for our employees to achieve personal success.

Sirtex offers qualified candidates:

Diverse and flexible work arrangements to achieve the optimum balance between work and personal responsibilities.
A culture of respect, diversity, collaboration, and innovation fostering inclusiveness and superior performance.
Attractive compensation and benefit packages which are practical, robust and equitable.
A commitment to support ongoing professional growth through career development, on the job experiences and training opportunities.
Challenging work which supports the development of new and better ways to improve clinical outcomes for oncology treatment around the world.
An unwavering commitment to company values, employee safety and excellence in everything we do.

Diversity drives innovation; inclusion fosters belonging, growth and success. Sirtex believes that it takes multiple perspectives and voices to create a culture and workplace which fosters engagement, teamwork, and employee satisfaction to perform our best and deliver on commitments. We are dedicated to fostering an environment where all employees feel valued, included, and can share their ideas so that we can exceed even our own expectations. Sirtex is An Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status, age or any other characteristic protected under applicable law. Sirtex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

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