Jobs in the United States

25+ jobs

Save this search

Added 1 min ago
Six Sigma Black Belt - Jackson Area
The Pivot Group Network
Jackson · Jackson, MI
Lead cross functional teams on process improvement projects.
Added 1 min ago
NPI Engineer - Shelby Township Area
The Pivot Group Network
Shelby Township · Shelby Township, MI
Launch Engineer, Manufacturing Project Engineer, Design for Manufacturing Engineer, New Product Introduction Engineer, Manufacturing Engineer, Process Engineer, Production Engineer, Product…
Added 1 min ago
Applications Engineer - Houghton Area
The Pivot Group Network
Houghton · Houghton, MI
Technical Sales Engineer, Estimator, Production Engineer, Mechanical Engineer, Industrial Engineer, Field Applications Engineer, Manufacturing Engineer, Sales Engineer, Process Engineer,…
Added 1 min ago
Continuous Improvement Manager - Wixom Area
The Pivot Group Network
Wixom · Wixom, MI
Operational Excellence Manager, Continuous Improvement Engineer, Lean Coordinator, Manufacturing Process Engineer, Quality Improvement Manager, Operations Improvement Specialist, Kaizen…
Added 1 min ago
Tooling Engineer - Cheboygan Area
The Pivot Group Network
Cheboygan · Cheboygan, MI
Production Engineer, Mechanical Engineer, Manufacturing Engineer, Tool Design Engineer, Process Engineer, Fixture Design Engineer, Tooling Specialist, Die Engineer, Mold Design Engineer
Added 1 min ago
Quoting Specialist - Houghton Area
The Pivot Group Network
Houghton · Houghton, MI
Request material and outside process pricing from approved suppliers.
Added 1 min ago
Manufacturing Engineer - Caro Area
The Pivot Group Network
Caro · Caro, MI
Production Engineer, Continuous Improvement Engineer, Lean Manufacturing Engineer, Manufacturing Systems Engineer, Operations Engineer, Methods Engineer, Tooling Engineer, Process Engineer,…
Added 1 min ago
Tooling Engineer - Grayling Area
The Pivot Group Network
Grayling · Grayling, MI
Mechanical Engineer, Manufacturing Engineer, Tool Design Engineer, Process Engineer, Fixture Design Engineer, Tooling Specialist, Die Engineer, Mold Design Engineer, Production Engineer
Added 1 min ago
Quoting Specialist - Iron River Area
The Pivot Group Network
Iron River · Iron River, MI
Request material and outside process pricing from approved suppliers.
Added 1 min ago
Quoting Specialist - Petoskey Area
The Pivot Group Network
Petoskey · Petoskey, MI
Work with engineering and production to confirm lead times and feasibility.
Added 1 min ago
Tooling Engineer - Saginaw Area
The Pivot Group Network
Saginaw · Saginaw, MI
Fixture Design Engineer, Tooling Specialist, Die Engineer, Mold Design Engineer, Production Engineer, Mechanical Engineer, Manufacturing Engineer, Tool Design Engineer, Process Engineer
Added 1 min ago
Six Sigma Black Belt - Livonia Area
The Pivot Group Network
Livonia · Livonia, MI
Lead cross functional teams on process improvement projects.
Added 1 min ago
Quoting Specialist - Croswell Area
The Pivot Group Network
Croswell · Croswell, MI
Work with engineering and production to confirm lead times and feasibility.
Added 39 mins ago
Systems Integration Lead / Process Engineer
Clear Labs
San Carlos, CA
We're hiring a Systems Integration Lead to sit at the interface between assay science and automation engineering - taking benchtop assays and redesigning them into automation-friendly,…
Added 52 mins ago
Electrical Controls Engineer IV
Lake Superior Consulting
Traverse City, MI · Houston, TX · Minneapolis, MN · Nashville, TN · Duluth, MN · Cranberry Township, PA · Omaha, NE
Execute project assignments as the discipline lead, subject matter expert, and engineer of record
Added 58 mins ago
Cost Planning Principal Engineer
Honda Dev. and Mfg. of Am.,LLC
Raymond, OH
The Cost Planning Engineer deeply understands the Design Category's cost situation. This position can identify concerns with cost accuracy or efficiency and suggest options for cost…
Added 1 hour ago
Electrical Engineer
AMRON - DIV OF AMTEC CORP
ANTIGO, WI
Added 1 hour ago
CNC Operator
STOUGHTON TRAILERS LLC
STOUGHTON, WI
…that require technical support with appropriate Technician and Engineer. Communicate status with Line Lead and Production Supervisor. Work with team members in pre and post line operations…
Added 1 hour ago
Automation Engineer
PHILLIPS MEDISIZE HUDSON ST CROIX
HUDSON, WI
JOB REQUIREMENTS: Your Job Molex is seeking a new Automation Engineer to join our team in Hudson, WI.We are expanding our production capabilities and seeking a new team member to help…
Added 1 hour ago
Advanced Manufacturing Engineer
PHILLIPS MEDISIZE HUDSON ST CROIX
HUDSON, WI
JOB REQUIREMENTS: Your Job Molex, LLC is seeking an Advanced Process Engineer to join our team in Hudson, WI. In this role, you will be part of a small, highly experienced engineering team…
Added 1 hour ago
CNC Operator
STOUGHTON TRAILERS LLC
STOUGHTON, WI
…that require technical support with appropriate Technician and Engineer. Communicate status with Line Lead and Production Supervisor. Work with team members in pre and post line operations…
Added 1 hour ago
Quality Engineer
KOCH INDUSTRIES INC
HUDSON, WI
Added 1 hour ago
Staff Engineer Electrical Engin
REHLKO
KOHLER, WI
Added 1 hour ago
Manufacturing Engineer
AMRON - DIV OF AMTEC CORP
ANTIGO, WI
Added 1 hour ago
CNC Operator
STOUGHTON TRAILERS LLC
STOUGHTON, WI
…that require technical support with appropriate Technician and Engineer. Communicate status with Line Lead and Production Supervisor. Work with team members in pre and post line operations…

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 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.

Apply About employer

Report this job