Jobs in the United States

25+ jobs

Save this search

Added just now
Mechanical Engineer, Prin
Quanta Power Solutions, LLC
Birmingham, AL
Quanta Power Solutions is seeking a highly experienced Principal Mechanical Engineer to serve as a senior technical authority and engineering leader for mechanical systems supporting power…
Added just now
Principal Field Service Engineer
PulseForge, Inc.
Austin, TX
Principal Field Service Engineer – Austin Texas Location
Added just now
Structural Engineer in Training
Colliers Engineering & Design
Austin, TX · Houston, TX
Colliers Engineering & Design is seeking a Structural Engineer in Training (EIT) to join its Structural Engineering team in either the Austin, TX or Cypress, TX office.
Added 1 min ago
Building Engineer I
at Marriott
San Antonio, TX
…disabilities, and thank guests with genuine appreciation. Adhere to quality expectations and standards. Develop and maintain positive working relationships with others, support team to…
Added 2 mins ago
Manufacturing Engineer - IA
Van-Am Tool & Engineering
Waverly, IA
We are looking for an engineer who enjoys solving complex manufacturing challenges, improving production processes, designing tooling and fixtures, and collaborating with production,…
Added 3 mins ago
SO
GEOTECHNICAL ENGINEER (CIVIL ENGINEER V)
State of Illinois
Peoria, IL
- $6,837 to $10,831 USD / month
Develops and implements district quality standards involving soil structure conditions.
Added 3 mins ago
Data Scientist
S&P Global Inc.
NY
The AI Data Engineer will specialize in building and optimizing machine learning data pipelines, focusing on AI model tracking, lifecycle management, and integration with AI governance…
Added 3 mins ago
Sterile Processing Tech (FR)
Northwell
Valley Stream, NY
Identifies malfunctioning items, records related information, and promptly notifies supervisor or biomedical engineer.
Added 3 mins ago
Audience & Insight Analyst
Infillion
NY
…thinking and technical fluency. You do not need to be a software engineer, but you should be comfortable working in technical environments, learning new tools quickly, using SQL and AI…
Added 3 mins ago
Data Engineer
Kinsale Management, Inc.
Richmond, VA
As a Data Engineer, you’ll join our Technology team and play an influential role in developing, testing, and deploying data solutions that drive quality and efficiency across the business.…
Added 3 mins ago
G
Civil Engineer - Land Development Background
GPAC
San Diego, CA
- $85,000 to $115,000 USD / year
The Land Development Civil Engineer plans and conducts work requiring judgment regarding the independent evaluation, selection, and substantial adaptation and modification of standard…
Added 3 mins ago
G
Water/Wastewater Engineer PM/PE
GPAC
Wilmington, 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 4 mins ago
Senior Software Engineer, Data Engineering
Flatiron Health
NY
We're looking for a customer-obsessed Senior Data Engineer to help us accomplish our mission to improve and extend lives by learning from the experience of every person with cancer. Are you…
Added 4 mins ago
Senior Software Engineer, Data Engineering
Flatiron Health
NY
We're looking for a customer-obsessed Senior Data Engineer to help us accomplish our mission to improve and extend lives by learning from the experience of every person with cancer. Are you…
Added 5 mins ago
Backend Software Engineer II
US Venture
Appleton, WI
The Backend Software Engineer II plays a vital role as an independent contributor, focusing on the development of moderately complex backend features and services. This position involves…
Added 5 mins ago
Structural Restoration Consultant/Engineer
Walker Consultants
Rockville, MD
Added 5 mins ago
G
Civil Engineer - Land Development Background
GPAC
Irvine, CA
- $85,000 to $115,000 USD / year
The Land Development Civil Engineer plans and conducts work requiring judgment regarding the independent evaluation, selection, and substantial adaptation and modification of standard…
Added 5 mins ago
Principal Embedded Software Engineer - FPGA
Stryker Employment Company, LLC
Portage, MI · Grand Rapids, MI
The Principal Embedded Software Engineer (FPGA) is a technical leadership role responsible for architecting and guiding the development of complex FPGA-based and embedded software systems…
Added 5 mins ago
Post Market Surveillance Engineer II
Integer
Plymouth, MN
You adhere to Integer’s Values and all safety, environmental, security and quality requirements including, but not limited to: Quality Management Systems (QMS), Safety, Environmental and…
Added 5 mins ago
Manufacturing Engineer
Bosch Group
Florence, KY
The Manufacturing Engineer will be responsible for supporting the planning of new equipment and processes within the Electric Rack Steering assembly area. This position supports equipment…
Added 5 mins ago
GTM Engineer
Legalist
Remote, United States
Legalist is looking for a GTM Engineer to join our team and build the systems, workflows, and automation that power our go-to-market motion. This is a hands-on, execution-focused role for…
Added 5 mins ago
Quality Engineer
OPmobility
Spring Hill-Tennessee, TN
As a Plant Quality Engineer, you will work closely with Production, Engineering, Supply Chain, and Customer teams to build a broad understanding of automotive manufacturing operations while…
Added 7 mins ago
Sr Design Engineer
CIRCOR International, Inc.
Tampa, FL
…designers, suppliers, and other applicable (production, sales, quality, et cetera) departmental assignees to solicit technical information as well as production capabilities to develop…
Added 7 mins ago
G
Water/Wastewater Engineer PM/PE
GPAC
High Point, 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 7 mins ago
G
Water/Wastewater Engineer PM/PE
GPAC
Concord, 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…

Sirtex

Senior Product Development Engineer

Woburn, MA, United States

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

Apply About employer

Applications open in a new tab.

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.

Apply About employer

Report this job