Jobs in the United States

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Added 1 min ago
Quality Engineer Level 2 or Level 3
Northrop Grumman
Corinne, UT
Northrop Grumman’s Space Sector is seeking a Quality Engineer – Level 2 or Level 3 to join our team in Promontory, UT . This position is 100% onsite and cannot accommodate telecommute work.
Added 1 min ago
Principal Propulsion Engineer - 3
Northrop Grumman
Corinne, UT
We are seeking a highly motivated and detail-oriented Principal Propellant Materials and Process Engineer to join our team. In this role, you will be responsible for supporting all aspects…
Added 1 min ago
Business Development Manager
Schlumberger
West Valley City, UT
We are seeking an experienced Business Development Sales Engineer to drive growth and diversification of our advanced microelectronics and Multi-Chip Module (MCM) manufacturing business.
Added 1 min ago
Facilities Engineer II
Westinghouse Electric Company, LLC
Hopkins, SC
As a Principal Facilities Mechanical Engineer, you will provide senior technical leadership and facilities mechanical engineering support for the LEU+ Fuel Fabrication Facility Construction…
Added 1 min ago
Cleared Electrical Engineer
KIHO MILITARY ACQUISITION CONSULTING, INC.
OGDEN, UT
…lifecycle phases including concept development, engineering and manufacturing development, production, deployment, and operations & support Translate DoD user requirements into system…
Added 1 min ago
Quality Engineer II, Sustaining & Validation
ICU MEDICAL INC
SALT LAKE CITY, UT
Added 1 min ago
Quality Engineer II, Sustaining
ICU MEDICAL INC
SALT LAKE CITY, UT
Added 1 min ago
Capital Projects Engineer
HEXCEL CORPORATION
SALT LAKE CITY, UT
Added 1 min ago
Sr Project Manager - AI Data Centers
Jacobs
Salt Lake City, UT
…recognized hyperscale owners, colocation operators, and advanced manufacturing clients in the industry. At Jacobs, you will do what you are most passionate about, at a scale and with a…
Added 1 min ago
Lead, Manufacturing Engineering
L3Harris Technologies
Wilmington, MA
The Operations Organization is seeking a talented and creative Lead Manufacturing Engineer to support several key programs at L3Harris's Imaging Division, which has experienced significant…
Added 1 min ago
Field Engineer
FRONTLINE
SALT LAKE CITY, UT
Added 1 min ago
Senior Controls Engineer
WYNRIGHT CORPORATION
SALT LAKE CITY, UT
Senior Controls Engineer Job Location US | US-MI-Grand Rapids | US-IL-Bolingbrook | US-UT-Salt Lake City | US-TX-Fort Worth | US-KY-Erlanger # of Openings 1 Shift 1st Shift Company Division…
Added 2 mins ago
Instrumentation & Controls Engineer (45212)
Jacobs
Salt Lake City, UT
We are seeking an Instrumentation & Controls Engineer to support automation and facility control systems for advanced manufacturing and semiconductor facilities. Based in Boise, you'll work…
Added 2 mins ago
Electrical Engineer (47064)
Jacobs
Salt Lake City, UT
We’re looking for an Intermediate Electrical Engineer to join our team who is excited about working on projects that enable the heart of our clients’ business. Join us and you will have the…
Added 2 mins ago
CMC Mechanical Analysis Lead Engineer
GE Aerospace
Salt Lake City, UT
The Lead Engineer will be responsible for supporting and leading mechanical analysis projects for CMC hot section hardware and/or interfacing metallic components with specific focus on…
Added 2 mins ago
Program Manager- Manufacturing Transformation
Medtronic
Salt Lake City, UT
The Program Manager is responsible for leading a portfolio of complex, cross-functional capacity expansion and manufacturing transformation initiatives. This role serves as the primary…
Added 3 mins ago
Mechanical Engineer, Prin
Quanta Power Solutions, LLC
Birmingham, AL
Quanta Power Solutions is seeking a highly experienced Principal Mechanical Engineer to serve as a senior technical authority and engineering leader for mechanical systems supporting power…
Added 4 mins ago
Principal Field Service Engineer
PulseForge, Inc.
Austin, TX
Principal Field Service Engineer – Austin Texas Location
Added 4 mins ago
Network Overlay Engineer
RMC Global
Remote, United States
RMC is seeking a Network Overlay Engineer for a full-time 100% remote position!
Added 5 mins ago
Manufacturing Engineer - IA
Van-Am Tool & Engineering
Waverly, IA
Van-Am Defense Systems is seeking an experienced Manufacturing Engineer to join our engineering team in Waverly, Iowa. This is an opportunity to make a direct impact on the manufacturing of…
Added 9 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 9 mins ago
Post Market Surveillance Engineer II
Integer
Plymouth, MN
…in support in your development as a Post Market Surveillance Engineer…
Added 9 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 9 mins ago
Quality Engineer
OPmobility
Spring Hill-Tennessee, TN
As a Plant Quality Engineer, you will work closely with Production, Engineering, Supply Chain, and Customer teams to build a broad understanding of automotive manufacturing operations while…
Added 10 mins ago
Sr Design Engineer
CIRCOR International, Inc.
Tampa, FL
The Senior Design Engineer participates in the design and evaluation of production processes for both new and existing products and systems to provide improvements in cost, performance or…

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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