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Power System Panel Design Engineer - Grid Automation
GE Grid Solutions, LLC
United States
GE Vernova’s Grid Automation Control & Protection panel design engineer is a hands-on, high-impact engineering role responsible for owning the design, programming, testing, and…
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Water/Wastewater Engineer PM/PE
GPAC
Durham, NC
- $105,000 to $140,000 USD / year
Are you a Professional Engineer with experience in water and wastewater infrastructure looking for your next career opportunity? A well-established and growing engineering team is seeking a…
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Senior Instrumentation and Controls Engineer
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Rockville, MD
Our Senior Instrumentation and Controls Engineer is responsible for supporting the design and development of instrumentation and controls (I&C) through all phases of the design lifecycle,…
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Field Engineer
Terracon
Raleigh, NC
…specifications. Prepare proposals and cost estimates, track and evaluate project progress, budgets, and recommend changes. Research and resolve design and construction problems. Assign,…
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Piping Engineer
Actalent
Downers Grove, IL
- $35 to $48 USD / hour
Job Title: Piping Engineer (Stress Engineer I)Job DescriptionThis early-career Piping Engineer role focuses on piping stress analysis, system flexibility, piping supports, and mechanical…
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Quality Manager
Actalent
Warsaw, IN
- $45 to $53 USD / hour
Plan, organize, and lead quality projects by defining activities, sequencing tasks, and establishing realistic timelines.
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Electrical Engineer
Actalent
Clintonville, WI
- $80,000 to $120,000 USD / year
…Participate in arc flash, LOTO, and electrical risk assessments. Lead or support capital projects and continuous improvement initiatives. Create and maintain electrical drawings, standards,…
Added 1 min ago
A
Piping Engineer
Actalent
Downers Grove, IL
- $35 to $48 USD / hour
Job Title: Piping Engineer (Stress Engineer I)Job DescriptionThis early-career Piping Engineer role focuses on piping stress analysis, system flexibility, piping supports, and mechanical…
Added 3 mins ago
Systems Engineer
Sonalysts, Inc.
Waterford, CT
Sonalysts, Inc. is seeking an experienced systems engineer to provide engineering support to a DoD weapon acquisition program. The successful candidate will manage Systems Engineering…
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Water/Wastewater Engineer PM/PE
GPAC
Winston Salem, NC
- $105,000 to $140,000 USD / year
Are you a Professional Engineer with experience in water and wastewater infrastructure looking for your next career opportunity? A well-established and growing engineering team is seeking a…
Added 3 mins ago
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Water/Wastewater Engineer PM/PE
GPAC
Cary, NC
- $105,000 to $140,000 USD / year
Are you a Professional Engineer with experience in water and wastewater infrastructure looking for your next career opportunity? A well-established and growing engineering team is seeking a…
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Water/Wastewater Engineer
Mott MacDonald
Iselin, NJ
Working under the supervision of a project manager or senior project engineer
Added 4 mins ago
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Water/Wastewater Engineer PM/PE
GPAC
Fayetteville, NC
- $105,000 to $140,000 USD / year
Are you a Professional Engineer with experience in water and wastewater infrastructure looking for your next career opportunity? A well-established and growing engineering team is seeking a…
Added 5 mins ago
Lead Engineer - Mechanical
McKinstry Company
Seattle, WA
We are currently seeking aLeadElectricalEngineer to join our Engineering and Design team in Seattle, WA. As the Lead Electrical Engineer, you will lead system design, coordination between…
Added 6 mins ago
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Civil Project Manager-PE/PM - Wentzville
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Wentzville, MO
- $120,000 to $165,000 USD / year
An established, nationally recognized multidisciplinary engineering consulting firm is seeking a Civil Site Engineering Project Manager to join its growing team. This is an opportunity to…
Added 8 mins ago
Field Engineer - Salt Lake City, UT
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SALT LAKE CITY, UT
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Production/Commissioning and Start-Up Engineer
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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…
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Business Development Manager
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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.
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Regional Technical Director
Barton Associates Inc
York, PA
Project and Construction Support: Oversee RFIs, submittals, site observations, and commissioning coordination. May serve as Engineer of Record or Project Manager on complex projects,…
Added 8 mins ago
Regional Technical Director
Barton Associates Inc
Philadelphia, PA
Project and Construction Support: Oversee RFIs, submittals, site observations, and commissioning coordination. May serve as Engineer of Record or Project Manager on complex projects,…
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Senior Electrical Engineer (Healthcare)
Barton Associates Inc
York, PA
The Senior Electrical Engineer leads electrical design for complex projects in the healthcare industry, including hospitals, ambulatory care centers, outpatient facilities, and renovations…
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Senior Software Engineer - Unified Orchestration
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Step into project leadership and feature-lead responsibilities at the senior level.
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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…
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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

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 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 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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