Jobs in the United States

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Added 15 mins ago
New Glenn Stage 2 Materials & Process Engineer II
Blue Origin Personnel, LLC
United States
We are looking for a self-motivated Material & Processes Engineer to apply their technical expertise, leadership skills, and commitment to quality to positively impact safe human…
Added 15 mins ago
Materials and Process Engineer II – Friction Stir Welding
Blue Origin Personnel, LLC
Space Coast, FL
Job Profile: Materials and Process Engineer II – Friction Stir Welding
Added 17 mins ago
WW
Sr. Systems Engineer
World Wide Technology
Maryland Heights, MO
- $120,000 to $130,000 USD / year
…for delivery, upgrade, and security updates. As the Senior Engineer Microsoft SME, you will be responsible for creating, managing, and seamlessly delivering the Windows desktop core build…
Added 22 mins ago
Field Service Engineer II
HITACHI ENERGY USA INC
Mount Pleasant, PA
…impact for customers? Join Hitachi Energy as a Field Service Engineer and become a trusted technical partner delivering world-class service and support for advanced industrial equipment and…
Added 25 mins ago
Software Development Engineer II, AWS Inspector
Amazon.com Services LLC
Herndon, VA
…will have past experience working as a software development engineer. You will enjoy keeping your technical skills current, to the point that you can contribute to architecture discussions.…
Added 27 mins ago
Design Engineer II
WARN INDUSTRIES INC
Clackamas, OR
We’re looking for a Design Engineer - Productivity and Sustainability who can turn engineering expertise into real, measurable improvements across our products and manufacturing operations.…
Added 29 mins ago
Software Engineer II, Backend
Affirm
Remote, United States
You will be matched with a team after completing the interview evaluation process. Your recruiter will work closely with you throughout the process to understand your interests and…
Added 29 mins ago
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Sr. Thermal Controls Systems Engineers
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Irvine, CA
- $135,000 to $203,000 USD / year
…experience in any occupation as thermal development and analysis engineer. Experience must include working with control systems fundamentals and their application to the thermal domain;…
Added 31 mins ago
Construction Inspector I or II - Graham Area Office
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…improvement projects. Responsible to a licensed professional engineer who has full authority for approval of all work. Work requires contact with contractors. May perform materials tests…
Added 31 mins ago
TS
Software Engineer II
TGW Systems Inc
Grand Rapids, MI
- $90,000 to $115,000 USD / year
The Software Engineer II is a mid-level engineer who works with a team of Software Engineers to design, develop, test, commission, and provide ongoing support of TGW software solutions.
Added 32 mins ago
Sr. Environmental Regulatory Engineer (Air Permitting)
SpaceX
Bastrop, TX · Brownsville, TX
We are looking for a senior engineer who has carried a complex industrial air permit from strategy through issuance and can explain the path to the people selecting equipment. Candidates…
Added 32 mins ago
Sr. Environmental Regulatory Engineer (Air Permitting)
SpaceX
Pecan Island, LA · Bastrop, TX · Brownsville, TX
We are looking for a senior engineer who has carried a complex industrial air permit from strategy through issuance and can explain the path to the people selecting equipment. Candidates…
Added 32 mins ago
Sr. Environmental Regulatory Engineer (Air Permitting)
SpaceX
Starbase, TX · Bastrop, TX · Brownsville, TX
We are looking for a senior engineer who has carried a complex industrial air permit from strategy through issuance and can explain the path to the people selecting equipment. Candidates…
Added 32 mins ago
Manufacturing Engineer (Starlink Development)
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Bastrop, TX
As a Manufacturing Engineer on the Development Operations team, you will own how Starlink hardware gets built. You will lead the factory projects that put new tooling and automation on the…
Added 32 mins ago
IT Network Infrastructure Engineer, Launch
SpaceX
Starbase, TX · Brownsville, TX
As a Network Infrastructure Engineer at SpaceX, you will work in a complex environment designing and supporting a variety of IT systems critical for Starship launch pads. This position will…
Added 42 mins ago
Software Development Engineer in Test II (SDET II)
Verisk | Verisk
Jersey City, NJ
…small number of agile teams serving as the Software Development Engineer in Test and drive all processes and tools used to achieve automated regression & functional testing. Prior…
Added 42 mins ago
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Software Engineer
Actalent
Irvine, CA
- $70 USD / hour
Software Engineer II Next-Generation Embedded & AI-Driven Platform Development
Added 50 mins ago
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Fire Captain (Volunteer/Stipend)
Arrowbear Lake Fire Department
Arrowbear Lake, CA
- $150 to $3,500 USD / month
· Three years of service functioning in the positions of fire apparatus engineer.
Added 52 mins ago
Software Engineer II, Arene Applied Engineering
Woven by Toyota
Ann Arbor, MI
This role is for a hands-on engineer who writes production C++ and owns the hard part of making software actually work with real vehicle hardware, ECUs, sensors, and networks. The strongest…
Added 55 mins ago
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Software Engineer Data & AI II (Full Time) – United States
Cisco
San Jose, CA
- Full-time
You are a passionate software engineer with expertise in developing scalable data pipelines, designing robust analytics platforms, and building infrastructure to support machine learning…
Added 55 mins ago
IT Systems Administrator (Multiple Levels)
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Chantilly, VA
…communication, deployment, and authentication platforms. The engineer delivers Tier II/III advanced engineering support and handles limited Tier I troubleshooting, escalations as needed,…
Added 59 mins ago
Process Engineer
Eichleay Main Career Page
Ferndale, WA
Eichleay is seeking a Process Engineer to join our team in Ferndale, Washington. This early-career role supports industrial and refinery clients while providing hands-on experience across…
Added 1 hour ago
Principal Network Engineer, AI Infrastructure (Starshield)
SpaceX
Washington, DC
As a Principal Network Engineer you will drive the operation, build and deployment of the Starshield data center network, which supports critical national security missions. You and your…
Added 1 hour ago
Quality Engineer
Icarus
El Segundo, CA
…posting. Your level will be determined during the interview process based on your technical skills, relevant experience, and demonstrated scope of…
Added 1 hour ago
GNC Engineer
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…posting. Your level will be determined during the interview process based on your technical skills, relevant experience, and demonstrated scope of…

Sirtex

Senior Product Development Engineer

Woburn, MA, United States

$94,970 to $118,712 USD / year

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Job details

Pay: $94,970 to $118,712 USD / year
Experience: BS degree in one of the above disciplines and 7+ years of medical device product development experience, or a MS with 5+ 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 Sr. 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 one of the above disciplines and 7+ years of medical device product development experience, or a MS with 5+ 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 $94,970 to $118,712 annually, plus a 5% 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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