Jobs in the United States

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Added 1 min ago
BG
Commissioning Engineer II
BEUMER Group
Denver, CO
- $105,000 to $115,000 USD / year
The Commissioning Engineer II plays a critical role in bridging software and automation development with operational deployment. This position is responsible for leading commissioning…
Added 1 min ago
PIT Operator
GXO Logistics
Port Allen, LA
We engineer faster, smarter, leaner supply chains.
Added 1 min ago
PIT Operator-PRT
GXO Logistics
Carlisle, PA
We engineer faster, smarter, leaner supply chains.
Added 1 min ago
LD
Value Engineer
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Remote, United States
- $145,000 to $165,000 USD / year
The Value Engineer leverages deep expertise in financial analysis, value-based selling, and digital banking domain knowledge to serve as a trusted advisor to both internal Sales teams and…
Added 2 mins ago
KC
Digital Content Specialist - Website & Social Media
KPFF Consulting Engineers
Remote, United States
- $37.5 to $46.8 USD / hour
Candidates must be based in the United States and able to work standard business hours a
Added 3 mins ago
Engineer Project Associate - Automotive Batteries
UL Solutions
Auburn Hills, MI
Added 3 mins ago
Engineer Project Associate - Circuit Protection
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Medicaid Data Lead
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Databricks Data Engineer Professional or relevant cloud certification.
Added 6 mins ago
Automation Engineer
Howmet Aerospace
Fullerton, CA
Howmet Fastening Systems (HFS) is seeking an Automation Engineer in our Fullerton, California location. HFS is a business unit of Howmet Aerospace, headquartered in Torrance, California. We…
Added 6 mins ago
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New York, NY · NY · Jersey City, NJ
As a Sr. Lead Software Engineer within Trust and Security at JPMorganChase, you will serve as a senior design authority for Customer Identity and Access Management solutions across web and…
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JPMC page
Tampa, FL
As a Software Engineer III at JPMorganChase within the Commercial & Investment Bank - Payments, Trust & Safety (Sanctions Screening) organization, you will serve as a seasoned member of an…
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Software Engineer III - Java/AWS/ MQ connectivity
JPMC page
Tampa, FL
As a Software Engineer III at JPMorganChase within the Commercial & Investment Bank - Payments, Trust & Safety (Sanctions Screening) organization, you will serve as a seasoned member of an…
Added 7 mins ago
Engineer - TrusSteel (Civil/Structural)
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This Engineer role is critical to Alpine’s mission of delivering high-quality software solutions and engineering services that improve productivity and profitability for component…
Added 7 mins ago
Deputy Project Manager
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Birmingham, AL
…technical experience, including signing and sealing of documents as Engineer or…
Added 7 mins ago
Principal Scientist/Engineer, Biomaterials & Toxicological Sciences
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Franklin, TN
Our client is seeking a Principal Scientist/Engineer, Biomaterials & Toxicological Sciences to work on-site in Franklin, TN. This role provides technical leadership in the evaluation,…
Added 7 mins ago
Snr. Electrical Engineer
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Houston, TX · Corpus Christi, TX
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Added 8 mins ago
Systems Test Engineer 2 - 31118
Huntington Ingalls Industries
Pocasset, MA
HII Unmanned Systems (HII UxS) are seeking an Integration and Test engineer for its UUV programs. As an I&T engineer on a UUV program, you will be part of an interdisciplinary approach to a…
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Process Engineer , Robotics Manufacturing and Technical Operations (RMTO) Process Engineering
Amazon
Westboro, MA
The Process Engineer will be responsible for the development, installation, validation, and optimization of complex manufacturing processes and systems used to produce robotics. This role…
Added 8 mins ago
Quality Engineer
Siemens
Hingham, MA
As a Quality Engineer within the world’s most respected manufacturer of automatic transfer switches and power control systems you will manage in-process and final inspection plans, drive…
Added 8 mins ago
AM
2027 Spring Process Engineer Co-op - Doctorate (Gloucester, MA)
Applied Materials
Gloucester, MA
- $47 to $50 USD / hour
Support laboratory and process development activities, including equipment preparation, wafer processing, wafer measurements and metrology, data collection and analysis, and documentation…
Added 8 mins ago
Senior Manufacturing Engineer
Dell Technologies
Franklin, MA
…contributing to a broader social mission as a Senior Manufacturing Engineer within our Global Test Engineering (GTE) Qualification group in Franklin,…
Added 8 mins ago
EC
Project Manager - Hyperscale
Eaton Corporation
Franklin, MA
- $99,000 to $145,000 USD / year
The primary function of a Field Based Project Manager is to create value and establish the project order management process as a key differentiator from our competitors. This position is…
Added 8 mins ago
Software Test & Integration Engineer
Leidos
Natick, MA
Position: Software Test & Integration Engineer
Added 8 mins ago
M
Senior Software Engineer
MathWorks
Natick, MA
- $186,160 to $210,400 USD / year
…reliability and usability requirements. Drive end-to-end development process from requirements and functional specifications through implementation and release. Work with quality…

Sirtex

Staff Product Development Engineer

Woburn, MA, United States

$123,612 to $154,515 USD / year

Apply on jobs.smartrecruiters.com About employer

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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 13, 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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More about this job

Skills

Leadership
Manufacturing processes
IDE
Documentation
Risk management
Root cause analysis
Inspection
Process improvement
Technical writing
Dassault Systemes SolidWorks
Statistics
Minitab
Reporting
Problem solving
Lean manufacturing
Coaching
Teamwork

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Work requirements

Jobs in the United States