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Added 1 min ago
Senior Engineer - Gas Engine Performance Assessment
INNIO
Waukesha, WI
We are seeking a Senior Engineer specializing in internal combustion engine performance to join our engineering team. In this role, you will lead and execute product development activities,…
Added 2 mins ago
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Senior Manufacturing Engineer
Toyon
Goleta, CA
- $130,000 to $200,000 USD / year
U.S. Citizenship is required. Candidates must be able to qualify for a U.S. Department of War Top Secret security clearance and obtain SAP program access.
Added 3 mins ago
Staff Interior Trim Design & Release Engineer
Rivian
Irvine, CA
Rivian seeks a Staff Design & Release Engineer to conduct development and end-to-end
Added 5 mins ago
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,…
Added 5 mins ago
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Continuous Improvement Engineer
Actalent
Bedford, OH
- $48 to $58 USD / hour
Job DescriptionThis hands-on Continuous Improvement Engineer role leads lean initiatives directly on the manufacturing floor while partnering closely with Operations leadership,…
Added 5 mins ago
A
Continuous Improvement Engineer
Actalent
Akron, OH
- $48 to $58 USD / hour
Job DescriptionThis hands-on Continuous Improvement Engineer role leads lean initiatives directly on the manufacturing floor while partnering closely with Operations leadership,…
Added 5 mins ago
Transmission Line Engineer
Actalent
Austin, TX
Job Title: Remote Transmission Line Engineer, PEJob DescriptionWe are seeking an experienced Transmission Line Engineer, PE to lead the engineering and design of high-voltage transmission…
Added 5 mins ago
Mechanical Engineer
Actalent
Denver, CO
Job Title: Mechanical EngineerJob DescriptionThis role offers an opportunity for an experienced Mechanical Engineer to take end-to-end ownership of advanced mechanical designs that support…
Added 5 mins ago
Mechanical Engineer
Actalent
Oklahoma City, OK
Job Title: Mechanical EngineerJob DescriptionThis role offers an opportunity for an experienced Mechanical Engineer to take end-to-end ownership of advanced mechanical designs that support…
Added 6 mins ago
Lead Fleet Performance Engineer
GE Vernova
Unspecified, GA
The engineer will work closely with Fleet Reliability & Root Cause Analysis (RCA), Controls Engineering, Data Analytics, AI, Field Service, Product Engineering, Quality, and R&D teams.
Added 6 mins ago
Finishing Lead
Graphic Packaging International, LLC
Perry, GA
…online at careers.graphicpkg.com or through MYHR under Finishing Lead…
Added 6 mins ago
Commissioning Manager - Power Plant (Multiple Locations) Job Details | Black & Veatch Family of Companies
Black & Veatch
Carrollton, GA
…matters - you own your work, your impact, and your future. We lead with care , and safety is non‑negotiable and embedded into every role, site and decision , ensuring our teams return home…
Added 6 mins ago
Senior Commissioning Manager - Power Plant (Multiple Locations) Job Details | Black & Veatch Family of Companies
Black & Veatch
Carrollton, GA
…matters - you own your work, your impact, and your future. We lead with care , and safety is non‑negotiable and embedded into every role, site and decision , ensuring our teams return home…
Added 6 mins ago
Commissioning Manager - Power Generation (Multiple Locations) Job Details | Black & Veatch Family of Companies
Black & Veatch
Carrollton, GA
5+ years of startup experience, with at least one previous assignment as a lead discipline engineer.
Added 6 mins ago
Head of Forward Deployed Engineering
Bausch + Lomb
Atlanta, GA
Bausch + Lomb is seeking a Head of Forward Deployed Engineer (FDE) to turn AI from pilots into production capability across B+L. This is a hands-on builder role embedded in manufacturing,…
Added 6 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 7 mins ago
Principal Software Development Engineer (AI Innovation)
CVS Health
Atlanta, GA
Lead engineering teams while maintaining a hands-on role as the primary point of contact for problem-solving to ensure high-quality, performant solutions.
Added 7 mins ago
Environmental Program Leader – Hazardous Waste and Dangerous Goods Compliance
GE Aerospace
Atlanta, GA
The Environmental Program Leader – Hazardous Waste and Dangerous Goods Compliance will provide enterprise leadership, technical expertise, and continuous improvement across hazardous waste…
Added 7 mins ago
Senior Geothermal Consultant Job Details | Black & Veatch Family of Companies
Black & Veatch
Atlanta, GA
…Geothermal Senior Consultant serves as a hands-on technical lead supporting engineering design, technical evaluations, and multidisciplinary integration of utility-scale geothermal surface…
Added 7 mins ago
Mechanical Engineer, Data Center Operations Engineering
Meta
Atlanta, GA
Meta is seeking a Mechanical Engineer to join our Data Center Operations Engineering team. Our data centers are the foundation upon which our rapidly growing infrastructure efficiently…
Added 7 mins ago
Supplier Quality Engineer - Airfoil Castings
GE Aerospace
Atlanta, GA
The Supplier Quality Engineer will drive quality for assigned suppliers, including quality plan implementation, & selecting suppliers through qualification processes. They will own supplier…
Added 7 mins ago
Director Project Controls (B&T)
Metropolitan Transportation Authority
NY
Lead Business Unit program and project control performance management and reporting activities
Added 7 mins ago
Senior Controls Engineer
FANUC America
Rochester Hills, MI
Lead the execution of electrical controls hardware and software activities for automation projects, ensuring quality and timely delivery.
Added 12 mins ago
Manufacturing Senior Engineer
Honda Dev. and Mfg. of Am.,LLC
Anna, OH
…Production to efficiently meet or exceed Safety, Environment, Quality, Delivery, Cost and Morale characteristics…
Added 13 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…

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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