Jobs in the United States

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Added 31 mins ago
Mechanial Engineer (R&D Engineer 2)
Los Alamos National Laboratory
Los Alamos, NM
…statistical analysis techniques. Experience with computer aid design tools such as SolidWorks, CREO, or Autodesk. Experience with computer programming languages; experience with Matlab,…
Added 31 mins ago
Systems Engineer (R&D Engineer 2 or 3)
Los Alamos National Laboratory
Los Alamos, NM
Leverage and database CAD drawings, manage inventories and equipment lists, and prepare engineering and work control documentation.
Added 31 mins ago
Weapons Product Definition Deputy Group Leader (R&D Manager 3)
Los Alamos National Laboratory
Los Alamos, NM
Experience using Creo Parametric CAD Software for 3D designs
Added 31 mins ago
R&D Engineer 2/3
Los Alamos National Laboratory
Los Alamos, NM
Development of novel render-safe tools and methods
Added 31 mins ago
R&D Engineer 3
Los Alamos National Laboratory
Los Alamos, NM
…student engineers. Contribute to ISR-5 mechanical engineering tools, methods, and best…
Added 31 mins ago
Mechanical Engineer (R&D Engineer 2)
Los Alamos National Laboratory
Los Alamos, NM
…statistical analysis techniques. Experience with computer aid design tools such as SolidWorks, CREO, or Autodesk. Experience with computer programming languages; experience with Matlab,…
Added 31 mins ago
Mechanical Engineer (R&D Engineer 2)
Los Alamos National Laboratory
Los Alamos, NM
…statistical analysis techniques. Experience with computer aid design tools such as SolidWorks, CREO, or Autodesk. Experience with computer programming languages; experience with Matlab,…
Added 31 mins ago
GT1 Mechanical Measurements
Sandia National Laboratories
Albuquerque, NM
…and surface texture/profile analyzers; applying solid model CAD/CAM software to generate profile definitions; performing complex and difficult setups using open set-up techniques; and…
Added 31 mins ago
Mechanical Engineering DE Analysis, Mid-level to Senior
AeroVironment
Albuquerque, NM
Use finite element analysis and other engineering tools to evaluate component and system performance.
Added 31 mins ago
CADD Operator II
Curia
Albuquerque, NM
Oversee the management of project-specific drawing libraries, file naming conventions, and CAD standards, ensuring proper version control, archival, and documentation practices.
Added 31 mins ago
Intern, R&D Undergraduate Summer - Measurement Science & Engineering, Onsite
Sandia National Laboratories
Albuquerque, NM
Proficiency with CAD software (e.g., SolidWorks, Inventor, or similar)
Added 32 mins ago
G
Electrical Design Engineer
GPAC
Charleston, SC
- $90,000 to $125,000 USD / year
Software Skills: Proficiency with industry-standard CAD software (e.g., AutoCAD Electrical, Altium Designer, OrCAD, or SolidWorks Electrical).
Added 32 mins ago
G
Electrical Design Engineer
GPAC
North Charleston, SC
- $90,000 to $125,000 USD / year
Software Skills: Proficiency with industry-standard CAD software (e.g., AutoCAD Electrical, Altium Designer, OrCAD, or SolidWorks Electrical).
Added 32 mins ago
G
Electrical Design Engineer
GPAC
Mount Pleasant, SC
- $90,000 to $125,000 USD / year
Software Skills: Proficiency with industry-standard CAD software (e.g., AutoCAD Electrical, Altium Designer, OrCAD, or SolidWorks Electrical).
Added 32 mins ago
G
Electrical Design Engineer
GPAC
Rock Hill, SC
- $90,000 to $125,000 USD / year
Software Skills: Proficiency with industry-standard CAD software (e.g., AutoCAD Electrical, Altium Designer, OrCAD, or SolidWorks Electrical).
Added 32 mins ago
G
Electrical Design Engineer
GPAC
Greenville, SC
- $90,000 to $125,000 USD / year
Software Skills: Proficiency with industry-standard CAD software (e.g., AutoCAD Electrical, Altium Designer, OrCAD, or SolidWorks Electrical).
Added 41 mins ago
UxS Integration Specialist
CACI International
Aberdeen Proving Ground, MD
Working knowledge of CAD, basic scripting, or networked systems
Added 41 mins ago
Maintenance Engineer Intern
Saint-Gobain
GAITHERSBURG, MD
…equipment, maintenance process (PMs & calibration), utilities, tools, and spare…
Added 55 mins ago
Lead Automation / Manufacturing Engineer
Eaton Corporation
Roxboro, NC
Drive continuous improvement utilizing lean tools
Added 55 mins ago
Lead NASCAR Aerodynamics Engineer
Oshkosh Corporation
Huntersville, NC
…findings into race vehicle specifications and into simulation tools. Working closely with the internal team of Aero/CFD/Design Engineers and Fabricators along with team resources, you will…
Added 56 mins ago
Measurement Lab Technician (Industrial Solutions) - Grade F ($26.52 - $31.83)
BorgWarner Inc.
Hendersonville, NC
Compare results to CAD Model or other digital data
Added 56 mins ago
Lead Machining Process Engineer
GE Aerospace
Asheville, NC
Define and control production processes including tooling and equipment. Validate design specifications and shop floor application of new product, tools, or equipment during trials, etc
Added 1 hour ago
Geospatial and Digital Innovation Development Leader
True Environmental
Remote, United States
…you will learn how each team delivers its work and build the tools, platforms, and workflows that make that work faster, more accurate, and more valuable to clients in the Transportation…
Added 1 hour ago
Senior Design Engineer
Divergent
Torrance, CA
…and mature high quality technical documentation, including CAD models, drawings, PMI’s, DFMEA’s, bills of material, and engineering…
Added 1 hour ago
Mechanical Designer IV
JPL/NASA
Pasadena, CA
Fluency in Engineering CAD (Computer-Aided Design) tools such as Siemens NX (required), CATIA or Creo.

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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