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Added 2 mins ago
Systems Engineer
Sonalysts, Inc.
Waterford, CT
Sonalysts, Inc. is seeking an experienced systems engineer to provide engineering support to a DoD weapon acquisition program. The successful candidate will manage Systems Engineering…
Added 3 mins ago
Analog Design Engineer
General Dynamics Mission Systems, Inc
McLeansville, NC
As an electrical engineer for UMS, you’ll be a member of a cross functional team responsible for designing complex undersea communication systems.
Added 7 mins ago
System Test Engineer
Northrop Grumman
Roy, UT
Northrop Grumman Defense Systems is seeking to hire a Systems Test Engineer . This position will be located in Roy, UT supporting the Sentinel Program.
Added 7 mins ago
Sentinel - Systems Engineer
Northrop Grumman
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Northrop Grumman Defense Systems is seeking a Systems Engineer to join our team. This position will be located at Roy, UT to support the Sentinel (GBSD) program in the Strategic Deterrent…
Added 7 mins ago
Quality Engineer II, Sustaining & Validation
ICU MEDICAL INC
SALT LAKE CITY, UT
Added 7 mins ago
Quality Engineer II, Sustaining
ICU MEDICAL INC
SALT LAKE CITY, UT
Added 7 mins ago
Senior Specialist, Electronic Warfare Systems Engineer
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The Electronic Warfare (EW) Systems Engineer will contribute to the life-cycle support of EW systems from conceptual development through product phase-out. This includes proposal support,…
Added 7 mins ago
Senior Cloud Engineer
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Added 7 mins ago
Senior Software Engineer - Operational Improvement
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SALT LAKE CITY, UT
Added 8 mins ago
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AI Engineer – Discovery
AstraZeneca
Cambridge, MA · Cambridge
- $124,000 to $187,000 USD / year
As a Cross-Disciplinary AI Engineer, you will work alongside researchers developing next-generation approaches in cell therapy, gene delivery, and oncology discovery. Much of the team’s…
Added 8 mins ago
SYSTEMS ENGINEER I/II – COMBAT SYSTEMS INTEGRATION
MIKEL INC
Middletown, RI
The Integration candidate will work as a key member of a highly skilled, multi-functional, and multi-disciplined team supporting Development, In-Service, and Shipset test environments.…
Added 9 mins ago
Test Automation & Verification Engineer
Apogee Engineering, LLC
Wright Patterson AFB, OH
Apogee is seeking a Test Automation & Verification Engineer to support the mission of the National Air and Space Intelligence Center (NASIC) at Wright Patterson AFB in Dayton, OH. In this…
Added 11 mins ago
Yard and Dock Coordinator - 1st Shift
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Locust Grove, GA
Strong communication skills with the ability to engage in daily customer-facing and cross-functional interactions
Added 15 mins ago
Principal Embedded Software Engineer - FPGA
Stryker Employment Company, LLC
Portage, MI · Grand Rapids, MI
The Principal Embedded Software Engineer (FPGA) is a technical leadership role responsible for architecting and guiding the development of complex FPGA-based and embedded software systems…
Added 16 mins ago
Sr Design Engineer
CIRCOR International, Inc.
Tampa, FL
…develop feasible design solutions. Hands-on participation in the test laboratory and related design validation as well as product preparation activities, with various service media and…
Added 17 mins ago
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Software Engineer
Auria (Boecore LLC)
Colorado Springs, CO
- $93,000 to $134,760 USD / year
Auria is looking to hire a skilled, results-oriented Software Engineer with multiple years of professional experience in one of our needed specialty areas? Are you looking for a challenging…
Added 17 mins ago
Salesforce DevOps Engineer
Steampunk
McLean, VA
We are seeking an experienced Salesforce DevOps Engineer to design, implement, and manage scalable CI/CD processes across our Salesforce environments. This role will be responsible for…
Added 17 mins ago
OS
Systems Engineer
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Colorado Springs, CO
- $31,533 USD / year
We are recruiting for a Journeyman Systems Engineer for the Engineering, Professional, and Administrative Support Services (EPASS) Contract at Peterson Space Force Base supporting SYD 85 in…
Added 18 mins ago
S
Senior Product Development Engineer
Sirtex
Woburn, MA
- $94,970 to $118,712 USD / year
Sirtex Medical is hiring a Sr. Product Development Engineer to serve as the senior individual-contributor technical authority. You will provide project leadership, own the technical…
Added 18 mins ago
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Staff Product Development Engineer
Sirtex
Woburn, MA
- $123,612 to $154,515 USD / year
Sirtex Medical is hiring a Staff Product Development Engineer to serve as the senior individual-contributor technical authority. You will provide project leadership, own the technical…
Added 20 mins ago
Senior Hardware Engineer
ASRC Federal
Colorado Springs, CO
As a Computer Systems Hardware Engineer you will be a key member of the Depot team responsible for sustainment and Depot Level Maintenance required for supporting the Upgraded Early Warning…
Added 23 mins ago
Lead Forward Deployed Robotics & Systems Engineer
Irving, TX
…inspect and correct installations, use hand tools and electrical test equipment, and diagnose problems across the machine, sensors, harnesses, power, networks, embedded compute and software…
Added 23 mins ago
Senior QA Engineer - Platform
Hard Rock Digital
Remote, United States
We are looking for a Senior QA Engineer to join the Platform team. Unlike a traditional feature-team QA role, you will own quality across the entire platform rather than a single feature…
Added 30 mins ago
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SQL System Engineer
ESM
Arlington, VA
- $106,000 to $128,000 USD / year
The SQL System Engineer Responsible for effective provisioning, operation, installation/configuration and maintenance of systems hardware/software/related infrastructure. Provide technical…
Added 32 mins ago
Lead Commissioning Engineer
OnQGlobal Inc
Muskogee, OK
OnQCx is seeking an experienced Lead Commissioning Engineer to develop Level 4 Functional Performance Test (FPT) procedures and Level 5 Integrated Systems Test (IST) scripts for large-scale…

Sirtex

Senior Product Development Engineer

Woburn, MA, United States

$94,970 to $118,712 USD / year

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Job details

Pay: $94,970 to $118,712 USD / year
Experience: BS degree in one of the above disciplines and 7+ years of medical device product development experience, or a MS with 5+ years.
Posting language: English
Posted: Nov 10, 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 Sr. 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 one of the above disciplines and 7+ years of medical device product development experience, or a MS with 5+ 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 anticipated annual base salary range and target bonus opportunity is $94,970 to $118,712 annually, plus a 5% target annual bonus. 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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