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Added 1 min ago
Manufacturing Engineer - IA
Van-Am Tool & Engineering
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We are looking for an engineer who enjoys solving complex manufacturing challenges, improving production processes, designing tooling and fixtures, and collaborating with production,…
Added 2 mins ago
SO
GEOTECHNICAL ENGINEER (CIVIL ENGINEER V)
State of Illinois
Peoria, IL
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Added 2 mins ago
Data Scientist
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NY
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Added 3 mins ago
Audience & Insight Analyst
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…thinking and technical fluency. You do not need to be a software engineer, but you should be comfortable working in technical environments, learning new tools quickly, using SQL and AI…
Added 3 mins ago
Data Engineer
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Richmond, VA
As a Data Engineer, you’ll join our Technology team and play an influential role in developing, testing, and deploying data solutions that drive quality and efficiency across the business.…
Added 4 mins ago
Structural Restoration Consultant/Engineer
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…require any accommodations during the application or interview process, or in the workplace, please let us know - we will work with you to ensure a fair and accessible…
Added 5 mins ago
Post Market Surveillance Engineer II
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You will perform work on projects where you will follow Integer’s standard quality management system methodologies to investigate opportunities for process improvements.
Added 5 mins ago
Manufacturing Engineer
Bosch Group
Florence, KY
The Manufacturing Engineer will be responsible for supporting the planning of new equipment and processes within the Electric Rack Steering assembly area. This position supports equipment…
Added 5 mins ago
Quality Engineer
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Conduct process, product, layered, and quality system audits to ensure compliance with IATF 16949 and internal standards.
Added 6 mins ago
Sr Design Engineer
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…designers, suppliers, and other applicable (production, sales, quality, et cetera) departmental assignees to solicit technical information as well as production capabilities to develop…
Added 7 mins ago
Software Engineer II -AI-Native - Branch Technology
JPMC page
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As a Software Engineer II at JPMorganChase within the Corporate Sector - Employee Platform team, you are part of an agile team that works to enhance, design, and deliver the software…
Added 7 mins ago
Software Engineer III - Node.js and TypeScript
JPMC page
Columbus, OH
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Added 7 mins ago
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Glass Research Engineer
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Littleton, CO
- $103,400 to $142,200 USD / year
Establish and maintain statistical process control (SPC) methodologies that consistently achieve glass compositional targets, product quality requirements, and manufacturing performance…
Added 7 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 7 mins ago
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Test Engineer
Booz Allen Hamilton
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- $86,800 to $198,000 USD / year
…and hardware testing. That's why we need an experienced test engineer like you who knows how to thoroughly test software and hardware and work with designers or developers to make sure our…
Added 7 mins ago
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Test Engineer
Booz Allen Hamilton
Colorado Springs, CO
- $86,800 to $198,000 USD / year
d test engineer like you who knows how to thoroughly test
Added 7 mins ago
BH
Senior Engineer, Advanced Engineering
Baker Hughes Energy
Boulder, CO
- $34,986 USD / year
As the Senior Engineer, Advanced Engineering, you will lead and support fitness-for-service (FFS), remaining-life, and asset integrity assessments of fixed, rotating, and pressure…
Added 8 mins ago
S
Senior Product Development Engineer
Sirtex
Woburn, MA
- $94,970 to $118,712 USD / year
Work in partnership with manufacturing and design quality to support transfer to manufacturing / Process Validation (IQ/OQ/PQ)
Added 8 mins ago
S
Staff Product Development Engineer
Sirtex
Woburn, MA
- $123,612 to $154,515 USD / year
Work in partnership with manufacturing and design quality to support transfer to manufacturing / Process Validation (IQ/OQ/PQ)
Added 9 mins ago
Manufacturing Engineer
ZF Group
Marysville, MI
About the Team: The Manufacturing Engineer will be based at ZF Axle Drives LLC in Marysville, Michigan, a state of the art facility that produces axle drives for OEM automotive companies.…
Added 9 mins ago
Sr. Specialist, Quality Assurance
Aecon
Charlotte, NC
The Senior Quality Assurance Specialist/Engineer serves as a key leader in maintaining and continuously improving the organization’s Quality Management System (QMS). This role is…
Added 11 mins ago
Manufacturing Quality Engineer
MANTECH
Remote, United States
MANTECH seeks a motivated, career and customer-oriented Manufacturing Quality Engineer to support the United States Space Force Space (USSF), Systems Command (SSC) in executing the National…
Added 12 mins ago
Partner Marketer
Cognition
San Francisco, CA
We're the makers of Devin, the first AI software engineer.
Added 12 mins ago
Sr. Engineer, Embedded Engineering-1131
Comcast (CC) of Willow Grove
PA
…use LinuxOS concepts including processes, scheduling, inter-process communication, and multithreading; perform version control using Git; build CI/CD pipelines using Jenkins; use test tools…
Added 13 mins ago
Lead Industrial Engineer
Anduril Industries
Quonset, RI
Design effective facility layouts and production lines using CAD and simulation which meet process requirements, enable production targets, optimize resource allocation and material flow,…

Sirtex

Staff Product Development Engineer

Woburn, MA, United States

$123,612 to $154,515 USD / year

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Job details

Pay: $123,612 to $154,515 USD / year
Experience: BS in Biomedical, Mechanical or a related engineering discipline with 10+ years of medical device product development experience, or MS with 8+ 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 Staff 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 in Biomedical, Mechanical or a related engineering discipline with 10+ years of medical device product development experience, or MS with 8+ 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 $123,612 to $154,515 annually, plus a 10% 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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