Jobs in the United States

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Added 4 mins ago
Senior Security GRC Engineer, AI & Automation
American Express Global Business Travel
Montpelier, VT
AmexGBT’s Security GRC team is looking for a talented Senior Security GRC Engineer to design, build, and scale automation and AI-driven solutions that modernize our governance, risk, and…
Added 4 mins ago
AI Operations Administrator - Gravitee - Remote US
SitusAMC
Montpelier, VT
…control baseline. The position works under the direction of senior engineering and architecture staff and provides a foundation for growth into the AI Operations Engineer…
Added 22 mins ago
Automation and Controls Engineer
CDM Smith
Dallas, TX
CDM Smith is seeking an Automation and Controls Engineer to help us grow our Automation services offerings throughout the Dallas area!
Added 2 hours ago
RH
Software Engineer
Robert Half
Remote, United States
- $55 to $63 USD / hour
…management, and interoperability solutions. We are seeking a Senior .NET Software Engineer with strong Microsoft technology expertise to design, build, and maintain scalable applications…
Added 2 hours ago
O
Core Infrastructure Engineer 2
Oracle
Nashville, TN
- $70,000 to $166,100 USD / year
…change, security, and compliance procedures (encryption, access controls, remediation plans) while escalating complex issues to senior…
Added 3 hours ago
Sr. DevOps Engineer
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Added 3 hours ago
Travel Senior MEP Project Manager-Mission Critical
STO Building Group
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Added 3 hours ago
Travel Senior MEP Project Manager-Mission Critical
STO Building Group
Eagle Mountain, UT
The Senior MEP Project Manager is responsible for the overall planning, management, and execution of work for assigned construction projects. May be assigned responsibility for one or more…
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Travel Senior MEP Project Manager-Mission Critical
STO Building Group
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The Senior MEP Project Manager is responsible for the overall planning, management, and execution of work for assigned construction projects. May be assigned responsibility for one or more…
Added 3 hours ago
Technical Services Engineer
Simr
Remote, United States
…troubleshoot common and complex issues and manage the escalation process (L1 & L2) to internal teams and senior engineers when…
Added 3 hours ago
Telecommunications Specialist 4 (Technical Specialist 4) - San Antonio, TX
M.C. Dean, Inc
San Antonio, TX
…electronic security, telecommunications, life safety, automation and controls, audiovisual, and IT systems. Headquarters in Tysons, Virginia, M.C. Dean delivers resilient, secure, and…
Added 3 hours ago
Senior Engineer, IAM Platform Engineering
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…IAM platform upgrades, automation enhancements, and security controls in development and test environments to ensure stability, performance, and regulatory compliance prior to production…
Added 3 hours ago
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Senior HVAC Mechanical Engineer
GPAC
Saint Louis, MO
- $120,000 to $150,000 USD / year
Are you a seasoned HVAC Mechanical Engineer who wants to design systems and then watch your own team build them? A well-established mechanical contractor in the St. Louis area is adding a…
Added 4 hours ago
Senior Process Integration Engineer
Samsung Austin Semiconductor, LLC.
Austin, TX
…sources to model yield by driving strong characterization of process variations that demonstrate a high-level understanding of key and critical controls necessary to achieve world class…
Added 4 hours ago
Senior Software Engineer
Boston Scientific
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Our Global Electrical Medical Equipment group is seeking a Senior Software Engineer to design, develop, test and maintain reliable, high-quality software for innovative medical technologies…
Added 4 hours ago
Senior End User Engineer
Berkeley Heights, NJ · Omaha, NE
The End User Computing Windows Engineer is responsible for providing technical support, maintenance, and optimization for end-user devices and applications, focusing on Windows operating…
Added 4 hours ago
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Senior Principal AI Research Engineer
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WA · CA · MA · CT · NY
- $139,100 to $231,900 USD / year
As a Senior Principal AI Research Engineer, you will build the machine learning systems that transform innovative models into secure, reliable, and scalable capabilities for scientists…
Added 4 hours ago
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Senior AI Research Engineer
Pfizer Inc
WA · CA · MA · CT · NY
- $106,000 to $176,600 USD / year
As a Senior AI Research Engineer, you will build the machine learning systems that transform innovative models into secure, reliable, and scalable capabilities for scientists across Pfizer.
Added 4 hours ago
Quality Assurance/Quality Control Manager
LEIDOS, INC.
San Diego, CA
…and standardizing SOPs, work instructions, quality plans, and process controls, rather than solely maintaining or auditing established…
Added 4 hours ago
Sr. Equipment Safety Engineer
SpaceX
Bastrop, TX
The SpaceX Environmental Health and Safety team is seeking a senior equipment safety engineer to provide strategic technical oversight of machine and equipment safety across manufacturing…
Added 5 hours 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 5 hours ago
Project Engineer, Mechanical
Veolia North America
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Project Engineer – Performs commissioning of mechanical systems. Must be a self-motivated & energetic professional. Must have understanding of building mechanical systems design,…
Added 5 hours ago
Platform Engineer, Cloud AI Infrastructure, Sr
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Portland, OR
The Senior Platform Engineer, Cloud & AI Infrastructure designs, builds, automates, and operates the secure cloud platforms that enable OnPoint’s AI, data, analytics, and automation…
Added 5 hours ago
Senior Core Infrastructure Engineer - OCI Product Catalog (Nashville-TN)
Oracle
Nashville, TN
We are looking for a Senior Core Infrastructure Engineer (IC3) with strong full-stack development experience to help design, build, and operate OCI Product Catalog.
Added 5 hours ago
Staff Engineer, Databricks Platform
Modernizing Medicine, Inc.
Boca Raton, FL
We are seeking a hands-on Senior/Staff Data Platform Engineer to own and evolve our established Databricks platform on AWS. The platform supports mission-critical data, analytics, and AI…

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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