Jobs in the United States

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Added 1 min ago
Mechanical Engineer- PCB
Actalent
Bastrop, TX
The Mechanical Engineer will support printed circuit board (PCB) manufacturing operations with a primary focus on process improvement, engineering experimentation, and the implementation of…
Added 1 min ago
Hardware Design Engineer Intern
Emerson
Round Rock, TX
Do you want to design the physical hardware that measures and controls the world’s most critical industrial processes? Emerson’s Process Systems and Solutions business develops automation…
Added 2 mins ago
Mechanical Project Engineer
Yearout Mechanical LLC
Amarillo, TX · Lubbock, TX · Wichita Falls, TX
As a Project Engineer, you’ll be the operational hub for complex mechanical (HVAC/Plumbing) projects - partnering with Project Managers and field teams to keep scope, schedule, cost,…
Added 2 mins ago
EC
Quality Systems Engineer, Programmatic
Eaton Corporation
El Paso, TX
- $86,000 to $126,000 USD / year
Establish standardized procedures, workflows, and process controls to improve consistency, compliance, and operational effectiveness.
Added 2 mins ago
Principal Product Engineer, Battery Management System (BMS)
Renesas
Plano, TX
The Principal Product Engineer for BMS is a highly experienced and technically proficient role responsible for the successful characterization, qualification, and high-volume manufacturing…
Added 2 mins ago
2027 Summer Corporate Intern - Engineering
Caterpillar, Inc.
San Antonio, TX · Fort Worth, TX
Process Engineering: Apply mechanical, manufacturing, systems and/or industrial engineering knowledge to analyze and optimize an engineering process or processes. Will have the opportunity…
Added 3 mins ago
A
Mechanical Application/Project Engineer
Actalent
Dallas, TX
- $70,000 to $90,000 USD / year
We are looking to hire is a Mechanical Project/Application Engineer to support the design, sizing, selection, and quoting of custom industrial equipment systems. This role is ideal for an…
Added 3 mins ago
Process Engineer - Manufacturing
System One
Houston, TX
We are seeking an experienced Process Engineer to join an established industrial manufacturing operation in the Houston area. This position is ideal for an engineer who enjoys working…
Added 3 mins ago
Advanced Lead Supplier Quality Engineer - Composites
GE Aerospace
Houston, TX
Position includes regular supplier audits and system assessments for quality preparedness and process controls to remain adherent to GE process specifications and agency regulations.
Added 3 mins ago
Engineer II, Process
IPS-Integrated Project Services
Blue Bell, PA
At IPS, we are global leaders in developing innovative solutions for the consulting, architecture, engineering, project controls, procurement, construction management, and CQV of…
Added 9 mins ago
Quality Manager
Nortek Air Solutions, LLC
Dyersburg, TN
Strengthen process capability through effective controls, standard work, and preventive quality practices.
Added 18 mins ago
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Product Engineer - Pumps
Pentair
Apex, NC
- $82,300 to $152,800 USD / year
We have an opportunity for a Product Engineer - Pumps - to join our Apex, NC team. You will serve as a technical resource to Product Management, Sales, Customer Service, Operations, and…
Added 28 mins ago
QA
Lead Facilities Technician
Quality Agents
Gaithersburg, MD
- $40 to $49 USD / hour
…utility systems, HVAC and building infrastructure that keep GMP manufacturing, laboratory and storage spaces running at client sites, around the clock where the site requires it.…
Added 34 mins ago
Sr. Automation & Controls Engineer, Insource Manufacturing (Starlink)
SpaceX
Bastrop, TX
SR. AUTOMATION AND CONTROLS ENGINEER, INSOURCE MANUFACTURING (STARLINK)
Added 43 mins ago
Sr. Manufacturing & Controls Engineer
Clarios
Saint Joseph, MO
The Sr. Manufacturing & Controls Engineer will ensure production equipment operates safely, reliably, and efficiently. This role will manage and support manufacturing projects of varying…
Added 43 mins ago
Bulk Senior Principal Process Engineer
CSL Behring L.L.C.
United States
Reporting to the Horizon 2 Process Area System Owner, this FTE role provides long-term technical and system ownership for bulk purification processes and equipment supporting the US Ig…
Added 43 mins ago
PTC Senior Principal Process Engineer
CSL Behring L.L.C.
United States
Reporting to the Horizon 2 Process Area System Owner, this FTE role provides long-term technical and system ownership for plasma pooling, thawing, bottle opening, and centrifugation…
Added 1 hour ago
Environmental Health & Safety Engineer (Satellites)
SpaceX
Redmond, WA
…pivotal role in providing technical EHS support to our satellite manufacturing teams. You will provide technical expertise and assist in the implementation of all environmental, health and…
Added 1 hour ago
RA
Sr. Embedded Software Engineers
Rivian and Volkswagen Group Technologies
Palo Alto, CA
- $188,000 to $220,000 USD / year
…field and 2 years of experience in any occupation as firmware engineer, software engineer, or related. Must have experience working with the following: Programming embedded firmware in C…
Added 1 hour ago
IG
Controls Engineer
Insight Global
North Charleston, SC
- $92,000 to $138,000 USD / year
The Controls Engineer is responsible for the design, programming, commissioning, troubleshooting, and continuous improvement of industrial automation and electrical control systems…
Added 1 hour ago
Engineer III/Sr. Engineer I, Manufacturing Sciences – Drug Product
Biogen
Research Triangle Park, NC
The Engineer III/Sr. Engineer I, Manufacturing Sciences serves as a key scientific and technical resource supporting aseptic drug product manufacturing at Biogen’s RTP Pharma facility. This…
Added 1 hour ago
Vehicle Management System (VMS) Requirements Engineer - Associate
The Boeing Company
Hazelwood, MO
…for an Associate Vehicle Management System (VMS) Requirements Engineer to join the VMS Requirements team located in Hazelwood,…
Added 1 hour ago
Vehicle Management System (VMS) Requirements Engineer - Senior
The Boeing Company
Hazelwood, MO
…opportunity for a Senior Vehicle Management System (VMS) Requirements Engineer to join the VMS Requirements team located in Hazelwood,…
Added 1 hour ago
Vehicle Management System (VMS) Requirements Engineer - Experienced
The Boeing Company
Hazelwood, MO
…an Experienced Vehicle Management System (VMS) Requirements Engineer to join the VMS Requirements team located in Hazelwood,…
Added 1 hour ago
Materials and Process Engineer III – Friction Stir Welding
Blue Origin Personnel, LLC
Space Coast, FL
Job Profile: Materials and Process Engineer III – Friction Stir Welding

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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