Jobs in the United States

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Added 1 min ago
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Development Engineer
Actalent
San Diego, CA
- $45 to $55 USD / hour
Job Title: Development EngineerJob DescriptionThe Development Engineer leads complex sustaining engineering projects across multiple products and sites, providing technical leadership and…
Added 1 min ago
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Hardware Test Engineer
Actalent
Orlando, FL
- $58 to $62 USD / hour
Job Title: Hardware Test Engineer IIJob DescriptionThe Hardware Test Engineer II supports the development, validation, and continuous improvement of advanced instrumentation, photonics,…
Added 1 min ago
Electrical Engineer
Actalent
Gilbert, AZ
Support continuous process improvement initiatives and contribute to engineering best practices.
Added 1 min ago
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Manufacturing Engineer
Actalent
REYNOLDSBURG, OH
- $31.25 to $36.06 USD / hour
Job Title: Manufacturing EngineerJob DescriptionThe Manufacturing Engineer will perform a wide range of electro-mechanical and multi-trade functions focused on the installation,…
Added 1 min ago
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Quality Engineer
Actalent
Upper Sandusky, OH
- $33.65 to $36.06 USD / hour
Job Title: Quality EngineerJob DescriptionThis Quality Engineer role focuses on investigating customer-reported product and quality issues, identifying root causes, and driving effective…
Added 1 min ago
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Quality Engineer
Actalent
Lebanon, OH
- $40.87 to $52.89 USD / hour
Job Title: Quality EngineerJob DescriptionThe Quality Engineer will play a vital role in supporting the development of quality systems, improving supplier processes, and ensuring customer…
Added 1 min ago
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Manufacturing Engineer
Actalent
Blue Ash, OH
- $80,000 to $125,000 USD / year
Provide process engineering support for the development, modification, and continuous improvement of manufacturing processes for custom aerospace components.
Added 1 min ago
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Mechanical Engineer
Actalent
Hudsonville, MI
- $38.46 to $42 USD / hour
The Mechanical Design Engineer will be responsible for the mechanical design and detailing of custom automated machines and fixtures, mechanical layouts, detail drawings, and BOMs. This…
Added 1 min ago
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Quality Manager
Actalent
Warsaw, IN
- $45 to $53 USD / hour
Evaluate process methods and equipment to ensure they meet performance and quality requirements.
Added 1 min ago
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Electrical Engineer
Actalent
Clintonville, WI
- $80,000 to $120,000 USD / year
…assessments. Lead or support capital projects and continuous improvement initiatives. Create and maintain electrical drawings, standards, and…
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Principal Embedded Software Engineer
Actalent
Oshkosh, WI
- $70 to $85 USD / hour
Ability to contribute to process improvement and best practices in embedded software development.
Added 1 min ago
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Hardware Engineer
Actalent
Winamac, IN
- $80,000 to $120,000 USD / year
Contribute to continuous improvement of hardware development processes, tools, and standards across the product lifecycle.
Added 2 mins ago
PC
Regional Wastewater Reclamation Department Director
Pima County
Tucson, AZ
- $146,286 to $219,398 USD / year
Directs capital improvement projects and provides for planning, construction oversight, inspection and maintenance of sanitary sewers, treatment plants and associated operations;
Added 3 mins ago
Associate Software Engineer (Hybrid)
Vizient, Inc.
Irving, TX
Vizient is seeking an entry-level Software Engineer to contribute to the design, development, testing, and delivery of scalable, secure, and user-centered software solutions.
Added 3 mins ago
CC
Design Quality Engineer
CONMED Corporation
Denver, CO
- $74,200 to $92,000 USD / year
The Design Quality Engineer is responsible for supporting all quality engineering activities to support the new product life cycle, from concept to commercialization, and sustaining…
Added 4 mins ago
Audio Tuning Engineer
Ford
Dearborn, MI · Dearborn
This role will support the development of tuning methodologies and execute the tuning process for future generations of vehicles.
Added 7 mins ago
Audio Tuning Engineer
Ford Global
Dearborn, MI
This role will support the development of tuning methodologies and execute the tuning process for future generations of vehicles.
Added 8 mins ago
Field Engineer - Salt Lake City, UT
ELECTRO TEST INC
SALT LAKE CITY, UT
Added 8 mins 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 8 mins ago
Production/Commissioning and Start-Up Engineer
Chart Industries
Orem, UT
We are seeking a dynamic and experienced Production/Commissioning and Start-Up Engineer to join our team at our Orem, UT location, developing the Cryogenic Carbon Capture process. This role…
Added 8 mins ago
Quality Engineer II, Sustaining & Validation
ICU MEDICAL INC
SALT LAKE CITY, UT
Added 8 mins ago
Quality Engineer II, Sustaining
ICU MEDICAL INC
SALT LAKE CITY, UT
Added 8 mins ago
Capital Projects Engineer
HEXCEL CORPORATION
SALT LAKE CITY, UT
Added 8 mins ago
Lead, Manufacturing Engineering
L3Harris Technologies
Wilmington, MA
Propose, develop and lead process improvement and cost reduction projects, apply lean liberally to the production cell.
Added 10 mins ago
SYSTEMS ENGINEER I/II – COMBAT SYSTEMS INTEGRATION
MIKEL INC
Middletown, RI
Participate in continuous process improvement and development of integration procedures, documentation, and technical practices.

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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