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Added 1 min ago
Customer Solutions Engineer I (CO)
ESPEC North America Inc
Aurora, CO
· Participates in ISO and Quality process as required.
Added 1 min ago
EN
Refrigeration Design Engineer II
ESPEC North America Inc
Hudsonville, MI
- $73,500 to $84,400 USD / year
· 4 to 8 years of professional experience in a manufacturing environment, serving as a mechanical, manufacturing, process, or project engineer required.
Added 2 mins ago
Davit Technician
Fairbanks Morse Defense
EDMONDS, WA
Job Title: Davit Technician / Davit Service Engineer
Added 2 mins ago
Project Engineer
The Christman Company
Grand Rapids, MI
…place for you! The Christman Company is looking for Project Engineer candidates for large-scale commercial construction projects in the greater Grand Rapids…
Added 2 mins ago
Operations Supply Chain Resiliency Project Manager
Siemens
Broken Arrow, OK
…cross-functional projects involving Procurement, Engineering, Quality, Manufacturing, Finance, and Logistics, working with internal and external stakeholders to execute moderately to highly…
Added 2 mins ago
Sr Assoc, Optical Engineer 1
L3Harris
Tulsa, OK
Job Title: Senior, Associate Optical Engineer
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AI Deployment Strategist
Zoom
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Engineer TTS components, including ElevenLabs, Azure, and Cartesia, to fine-tune tone, pacing, emphasis, and prosody to match conversation context and brand standards.
Added 2 mins ago
SOLUTION ENGINEER
Lumen
Oklahoma City, OK
…utilizing our technology services platform. The successful Solution Engineer must have a strong desire to leverage their technical and sales skills, including business acumen, to understand…
Added 2 mins ago
Capital One Shopping Tech, Data Engineer 5 (Remote- Eligible)
Capital One
Oklahoma City, OK
Architect and enforce common data engineering design patterns to ensure code quality, maintainability, and reusability across data platforms and pipelines
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Senior Full Stack Engineer – .NET & C#
Cognizant
Oklahoma City, OK
- $86,000 to $99,000 USD / year
As a Senior Full Stack Engineer – .NET & C#, you will make an impact by designing and developing scalable enterprise applications that support healthcare payer operations, including…
Added 2 mins ago
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Senior .NET Full Stack Engineer with C#
Cognizant
Oklahoma City, OK
- $86,000 to $99,000 USD / year
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Added 2 mins ago
Senior Workday Security Engineer
CVS Health
Oklahoma City, OK
…purpose, hold ourselves accountable and prioritize safety and quality in everything we do. Join us and be part of something bigger – helping to simplify health care one person, one family…
Added 2 mins ago
Senior Analyst, Product Engineer
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…database/general report and plan set up resources. SR Analyst, Product Engineer will set up the plans using a prototype control in CCI and PMA application to support the Small Group plans…
Added 3 mins ago
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Senior Support Engineer I
Cleo
Oklahoma City, OK
- $70,000 to $80,000 USD / year
…end-to-end resolution while driving improvements in ticket quality and…
Added 3 mins ago
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Director, Architecture and Data
GE Aerospace
Shawnee, OK · Oklahoma City, OK
- $152,000 to $202,000 USD / year
…governs – it sets the boundaries and guidelines the delivery process runs inside – while the data it curates is the foundation that process runs on. To make the data foundation real, the…
Added 4 mins ago
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Software Engineer Level 2 -FFNN-8973
Onyx Point, Inc.
Hanover, MD
- $78,000 to $250,000 USD / year
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Added 7 mins ago
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Staff Spacecraft Systems Engineer – Electronics
CesiumAstro
Westminster, CO
- $158,012 to $189,969 USD / year
The Staff Spacecraft Systems Engineer – Electronics provides technical leadership in the development, integration, verification, and lifecycle management of complex aerospace systems. This…
Added 8 mins ago
Quality Assurance Technician - Manufacturing
New Orleans, LA
Quality Technician, Inspector, or Engineer Certification
Added 10 mins ago
MI
Field Engineer - Electrical
MasTec Inc
Rapid City, SD
- $73,000 to $105,000 USD / year
The Field Engineer is responsible for managing the entire process of discipline-specific Construction Work Packages (CWPs) or Installation Work Packages (IWPs) for multiple disciplines.…
Added 10 mins ago
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Field Engineer
MasTec Inc
MOUNTAIN HOME, ID
- $70,000 to $90,000 USD / year
The Field Engineer I role will oversee and execute the project controls and management of a single discipline. The main functions of the Field Engineer I will include (but not limited to)…
Added 12 mins ago
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Software Engineer
Actalent
North Reading, MA
- $55 to $65 USD / hour
Job Title: Systems Software Engineer Robotics North Reading, MAOverviewWe are seeking a Systems Software Engineer to build the software foundation behind next-generation robotic vision test…
Added 12 mins ago
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BOM Engineer
Actalent
Grand Rapids, MI
- $25 to $30 USD / hour
Job Title: BOM Engineer / AnalystJob DescriptionThe BOM Engineer / Analyst plays a key role at the intersection of engineering and manufacturing by creating, maintaining, and improving…
Added 12 mins ago
Project Engineer
Actalent
Plano, TX
The Tooling Engineer/Project Mechanical Engineer will play a key role in the design, procurement, fabrication, assembly, integration, start-up, and commissioning of very large-scale…
Added 13 mins ago
Senior Manufacturing Process Engineer
Thales Defense & Security, Inc.
CLARKSBURG, MD
We are excited to announce that we have an opening in our Clarksburg, MD office for a Senior Manufacturing Process Engineer. This position reports into the Concurrent Engineering Manager…
Added 16 mins ago
Manufacturing Engineer
Central States Manufacturing
Lowell, AR
Summary: The Manufacturing Engineer will manage process definition, capital acquisition, and process implementation. They will also train employees as necessary and lead Kaizen events to…

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 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 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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