Jobs in the United States

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Added 1 min ago
BG
Commissioning Engineer II
BEUMER Group
Denver, CO
- $105,000 to $115,000 USD / year
As a family-owned company, BEUMER combines tradition with innovation. We are proud of what our employees create each day. Integrity, Inspiration, Quality and Teamwork!
Added 1 min ago
PIT Operator
GXO Logistics
Port Allen, LA
Demonstrate an understanding of the Supply Chain quality policy
Added 1 min ago
PIT Operator-PRT
GXO Logistics
Carlisle, PA
Demonstrate an understanding of the Supply Chain quality policy
Added 6 mins ago
Sr. Lead Software Engineer - Trust and Security
JPMC page
New York, NY · NY · Jersey City, NJ
As a Sr. Lead Software Engineer within Trust and Security at JPMorganChase, you will serve as a senior design authority for Customer Identity and Access Management solutions across web and…
Added 6 mins ago
Software Engineer III - Java/AWS/Kafka
JPMC page
Tampa, FL
As a Software Engineer III at JPMorganChase within the Commercial & Investment Bank - Payments, Trust & Safety (Sanctions Screening) organization, you will serve as a seasoned member of an…
Added 6 mins ago
Software Engineer III - Java/AWS/ MQ connectivity
JPMC page
Tampa, FL
As a Software Engineer III at JPMorganChase within the Commercial & Investment Bank - Payments, Trust & Safety (Sanctions Screening) organization, you will serve as a seasoned member of an…
Added 7 mins ago
Engineer - TrusSteel (Civil/Structural)
ITW Building Components Group Inc
Remote, United States
This Engineer role is critical to Alpine’s mission of delivering high-quality software solutions and engineering services that improve productivity and profitability for component…
Added 7 mins ago
Deputy Project Manager
Dewberry
Birmingham, AL
…we seek exceptional talent and strive to deliver the highest quality of services to our clients. Whether you’re an experienced professional or a new graduate, you’ll have the chance to…
Added 7 mins ago
Principal Scientist/Engineer, Biomaterials & Toxicological Sciences
PKR
Franklin, TN
Partner with product development, systems, mechanical, electrical, manufacturing, and quality engineers to build biological safety requirements into the design process early.
Added 8 mins ago
Snr. Electrical Engineer
Zachry Group
Houston, TX · Corpus Christi, TX
Zachry Group is currently looking talented and self-motivated Snr. Electrical Engineer with design experience to join our Electrical Department in Houston, Texas. This is a great…
Added 8 mins ago
Naval Architect Engineer 3 - 30097 1 1
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Pocasset, MA
As a Naval Architect / Marine Engineer, you will provide engineering leadership and shipyard‑focused expertise across the design, construction, integration, and test phases of a Medium…
Added 8 mins ago
Process Engineer , Robotics Manufacturing and Technical Operations (RMTO) Process Engineering
Amazon
Westboro, MA
The Process Engineer will be responsible for the development, installation, validation, and optimization of complex manufacturing processes and systems used to produce robotics. This role…
Added 8 mins ago
Quality Engineer
Siemens
Hingham, MA
As a Quality Engineer within the world’s most respected manufacturer of automatic transfer switches and power control systems you will manage in-process and final inspection plans, drive…
Added 8 mins ago
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Senior Software Engineer
MathWorks
Natick, MA
- $186,160 to $210,400 USD / year
…reliability and usability requirements. Drive end-to-end development process from requirements and functional specifications through implementation and release. Work with quality…
Added 8 mins ago
Quality Manager / Medical Devices
Kelly Services
Wilmington, MA
ASQ Certified Quality Engineer (CQE), Certified Quality Manager/Organizational Excellence (CQM/OE), or Certified Biomedical Auditor (CBA).
Added 8 mins ago
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Firmware Engineer Manufacturing Test Systems
ManpowerGroup
Wilmington, MA
- $65 to $70 USD / hour
Our client, a leader in robotics manufacturing and advanced automation, is seeking a Firmware Engineer to join their team. As a Firmware Engineer, you will be part of the Manufacturing Test…
Added 8 mins ago
Electrical Engineer I / PCB / Troubleshooting
Kelly Services
Wilmington, MA
A growing engineering and product development company is looking for an Electrical Engineer I to join its team developing innovative medical devices and robotic systems. This full-time…
Added 8 mins ago
Lead Perception Engineer
Kelly Services
Woburn, MA
An innovative robotics startup is seeking a Lead Perception Engineer to drive the development of advanced computer vision and AI-powered perception systems that are transforming the…
Added 8 mins ago
EC
Senior Manufacturing Engineer
Eaton Corporation
Worcester, MA
- $86,000 to $126,000 USD / year
Candidates must reside within 50 miles of the location on the job description
Added 8 mins ago
AI Engineer 5 (AI Foundations)
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Cambridge, MA
You love to build systems, take pride in the quality of your work, and also share our passion to do the right thing. You want to work on problems that will help change banking for good
Added 9 mins ago
Senior .NET Developer - .NET, C#, Angular, React, TypeScript
Kelly Services
Boston, MA
We are seeking a Senior .NET Software Engineer to join a growing technology team focused on delivering modern, scalable web applications and enterprise solutions. This role will play a key…
Added 9 mins ago
Application Platform Technical Lead
Kelly Services
Boston, MA
This is a unique opportunity for a senior-level engineer who wants to operate at the intersection of application development, cloud infrastructure, security, and platform architecture.…
Added 9 mins ago
State Revolving Fund (SRF) Program Manager
State of Massachusetts
Boston, MA
…preservation of the state's wetlands and coastal resources, air quality monitoring and pollution reduction, and so much more. Who We Are as an Employer: At EEA, we create meaningful,…
Added 9 mins ago
Lead .NET Developer - .NET, C#, Angular, React, TypeScript
Kelly Services
Boston, MA
We are seeking a Lead .NET Software Engineer to join a growing technology organization focused on developing modern web applications and enterprise software solutions. This role combines…
Added 9 mins ago
Senior Machine Learning Engineer
Kelly Services
Boston, MA
Senior Machine Learning Engineer – Robotics & Computer Vision

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 13, 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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More about this job

Skills

Leadership
Manufacturing processes
IDE
Documentation
Risk management
Root cause analysis
Inspection
Process improvement
Technical writing
Dassault Systemes SolidWorks
Statistics
Minitab
Reporting
Problem solving
Lean manufacturing
Coaching
Teamwork

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Work requirements

Jobs in the United States