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Added 1 min ago
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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…
Added 2 mins ago
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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…
Added 2 mins ago
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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…
Added 2 mins ago
I
Municipal Engineer
ISG
Dublin, OH
- $95,000 to $155,000 USD / year
…continued growth, we are seeking a talented and dedicated Civil Engineer to join our dynamic Public Works team. If you’re passionate about designing, building, and maintaining critical…
Added 3 mins ago
Software Engineer 2 - Mobile Developer (iOS & Android)
U.S. Bank
Atlanta, GA
This position will be responsible for the analysis, design, testing, development, and maintenance of best-in-class software experiences. The candidate is a self-motivated individual who can…
Added 3 mins ago
Sr. Controls Engineer, Data Center, Colocation Regional Engineering - AMER
Amazon
Atlanta, GA
As a Controls Colo Engineer, you will work with internal business teams and with colocation vendors to identify, document, and resolve any operational/design deficiencies which could impact…
Added 3 mins ago
Front End Web Applications Developer (Mid-Level) (5664)
SMX
Atlanta, GA
The SMX salary determination process takes into account a number of factors, including but not limited to, geographic location, Federal Government contract labor categories, relevant prior…
Added 3 mins ago
Front End Web Applications Developer (Junior) (5660)
SMX
Atlanta, GA
The SMX salary determination process takes into account a number of factors, including but not limited to, geographic location, Federal Government contract labor categories, relevant prior…
Added 3 mins ago
Associate Software Engineer
Highmark Health
Atlanta, GA
This job is an integral member of an agile software engineer team responsible for building scalable software applications across all digital channels to serve our customers. Responsible for…
Added 3 mins ago
Test Automation Engineer
Regions Bank
Atlanta, GA
At Regions, the Test Automation Engineer develops automated tests to validate the functionality of applications systems across various applications such as web, mobile, and mainframe.
Added 3 mins ago
Software Engineer 2
Humana
Atlanta, GA
The Software Engineer 2 develops, tests, and maintains software applications that support business and technology objectives. The associate works on moderately complex assignments,…
Added 3 mins ago
Project Engineer I
Honeywell Technologies
Atlanta, GA
As a Project Engineer I – Forge & AI, you will help drive execution across strategic technology, AI, and transformation priorities while serving as a key operational partner to the CTO,…
Added 4 mins ago
Airworthiness Engineer Specialist 3
Gulfstream
Savannah, GA
…and other foreign civil aviation authorities. Lead, generate, process, and support the review of engineering documentation required for certification programs from project start to closure.…
Added 4 mins ago
Director Project Controls (B&T)
Metropolitan Transportation Authority
NY
MTA Construction & Development reserves the right to remove this posting before the application deadline.
Added 5 mins ago
Computational Fluid Dynamics (CFD) Engineer
Brunswick Corporation
Fond du Lac, WI
As a Computational Fluid Dynamics (CFD) Engineer you will be a member of a team of analysis engineers supporting the design and development of conventional marine internal combustion…
Added 6 mins ago
CP
Investment Systems Engineer
Colorado Public Employees' Retirement Association
Denver, CO
- $108,000 to $134,000 USD / year
Owns medium investment projects by providing analysis, development, testing, and deployment; contributes to larger initiatives through effective collaboration with IT and Investment SMEs.
Added 9 mins ago
Manufacturing Senior Engineer
Honda Dev. and Mfg. of Am.,LLC
Anna, OH
…determines time standards, and makes recommendations for tooling and process requirements of new or existing product…
Added 10 mins ago
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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 10 mins ago
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Principal Product Development Engineer
Sirtex
Woburn, MA
- $150,553 to $175,000 USD / year
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…
Added 10 mins ago
S
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 11 mins ago
Quality Engineer
Magna Seating of America, Inc.
Lancaster, OH
…exciting, varied responsibilities as well as a wide range of development prospects. Because we believe that your career path should be as unique as you…
Added 12 mins ago
SA
Quality Engineer
Superior Air Parts
Coppell, TX
- $70,000 to $95,000 USD / year
Superior Air Parts is seeking an experienced Aerospace Quality Engineer to support supplier quality, product inspection, regulatory compliance and continuous improvement within our…
Added 16 mins ago
(DoW SkillBridge), Specialist, Quality Engineer
L3Harris Technologies
Palm Bay, FL
Space Systems team seeking a highly motivated and detail-oriented Quality Engineer. This role is responsible for ensuring the quality of products and processes across the lifecycle of a…
Added 17 mins ago
T-Ads Sr Engineer, Software Full Stack
T-Mobile USA, Inc.
Philadelphia, PA
5+ years full stack web development experience including front end and back end
Added 18 mins ago
Data Engineer II
CAI Cox Automotive Corp Svcs., LLC
Atlanta, GA
The Data Engineer II is responsible for processing structured and unstructured data, validating data quality, and developing and supporting data products. The Data Engineer also plays a…

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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