Provides technical expertise to the Risk Management Program, ensuring compliance with regulatory and business requirements for site products and product lines.
Responsibilities
Utilizes risk management engineering to ensure site compliance
Partners with Quality Systems staff and drives continuous improvement
Develops and maintains risk management files
Provides guidance during risk management review meetings
Provides risk management direction, training, and guidance to staff
Design Control Engineer contributor within the Product Quality organization, responsible for supporting the design and development of safe, effective, and compliant medical device products.
Responsibilities
Provide coaching and mentorship to development, manufacturing, and other stakeholders on content development, quality processes, risk analysis and Design Controls tools
Work with ALM developers to identify and capture learning content for tool features including best practices
Develop content for, review, and effectively deliver training to optimize efficacy and learner experience through channels such as online learning modules, instructor-led training, written instructional solutions, short content videos, and virtual training for users of Design Control tools
Respond to ticket-based requests from a variety of user channels supporting design teams
Research, recommend, and implement new authoring tools to improve learner experience
Requirements
Bachelor’s degree in engineering, science or other technical area
Lead product development for orthopedic implants and instruments from concept through design transfer.
Locations (2)
Broadview Heights, Ohio, United States
Jacksonville, Florida, United States
Responsibilities
Lead product development for orthopedic implants and instruments from concept through design transfer.
Author and execute test protocols and reports per ASTM/ISO standards, ensuring risk-based acceptance criteria and regulatory compliance.
Act as primary liaison with testing labs: prepare technical data packages, approve fixtures, clarify protocol details, and ensure proper sample handling and chain-of-custody.
Support lab test execution by coordinating logistics, reviewing set-up photos/videos, witnessing critical tests, and resolving deviations promptly.
Maintain design controls and risk management per ISO 14971 and 21 CFR 820 throughout the project lifecycle.
Lead and coordinate product cybersecurity activities across the AI Center of Excellence (AI COE).
Compensation
For U.S. based positions only, the pay range for this position is $105,600.00-$158,400.00 Annual. It is not typical for an individual to be hired at or near the top of the pay range and compensation decisions are dependent on the facts and circumstances of each case. The specific compensation offered to a candidate may be influenced by a variety of factors including skills, qualifications, experience and location. In addition, this position may also be eligible to earn performance based incentive compensation, which may include cash bonus(es) and/or long term incentives (LTI).
Responsibilities
Serve as the Product Security Representative and primary product cybersecurity point of contact for assigned AI COE products and programs.
Partner with engineering, ML, architecture, quality, regulatory, and Product Security teams to integrate cybersecurity requirements into product development and releases.
Ensure required product cybersecurity documentation and records are created and maintained throughout the product lifecycle.
Support vulnerability management, SBOM and third-party software security activities, including assessment and documentation of identified risks.
Requirements
Bachelor's degree in Computer Science, Software Engineering, Cybersecurity, Electrical Engineering, Biomedical Engineering, or a related technical field.
Lead complex, cross‑functional product development programs for dispenser and smart/IoT solutions portfolio, owning programs from concept through launch and post‑launch optimization.
Compensation
Salary Range: 105,740 – 130,620 USD
Responsibilities
Lead complex, cross‑functional product development programs
Own programs from concept through launch and post‑launch optimization
Coordinate work across hardware, firmware, software, and operations
Manage risks and tradeoffs
Keep stakeholders aligned
Requirements
Bachelor’s or advanced degree in a relevant engineering discipline
Nice to have: Master’s degree in technical field or business
Nice to have: IoT / connected devices
Nice to have: Smart products
Nice to have: Systems integrating hardware, firmware, and cloud services
Our client, a Medical Devices/Healthcare company, is looking for a Development Sr Engineer I for their Remote location.
Responsibilities
Supports remediation of existing product Design History Files (DHF) and Risk Management Files (RMF), closing documentation gaps and strengthening traceability.
Provides engineering support for product changes, design controls and quality activities.
Applies product, clinical, regulatory and standards knowledge to legacy DHF/RMF remediation.
Reviews available user needs and intended-use documentation for completeness and consistency.
Checks traceability among user needs, design inputs, outputs and supporting verification/validation evidence; documents gaps for remediation.
Requirements
Minimum B.S. degree from an ABET accredited school (or global equivalent) in one of the following engineering disciplines: Mechanical Engineering, Mechanical Engineering Technology, Biomedical Engineering, Bioengineering, Biomedical Engineering Technology, Bioengineering Technology, Aerospace Engineering or Aeronautical Engineering.
Lead systems engineering for Robotics Capital & instrument performance within next-generation medical devices and robotic applications, connecting capital equipment and instrument requirements to measurable performance.
Compensation
Pay range / Rango salarial / Intervalo salarial / Fascia retributiva / Tranche de salaire / Gehaltsband / Salaribereik: Ireland: 81,120.00 EUR - 121,680.00 EUR
Responsibilities
Lead systems engineering for instrument performance from stakeholder needs and product requirements through architecture, integration and verification.
Translate instrument and procedure needs into measurable system, subsystem and interface requirements with clear acceptance criteria.
Develop and maintain performance budgets for accuracy, force, torque, motion, latency and reliability across instruments, capital equipment and controls.
Own bidirectional traceability between requirements, risk controls, test methods and verification evidence.
Define system boundaries and interfaces between instruments, capital platforms, sensing, actuation, software and controls.
Requirements
Bachelor’s degree in Systems Engineering or a related engineering discipline
The Staff Quality Engineer serves as the Site Quality Lead and a member of the Site Leadership Team, providing strategic quality leadership across the product lifecycle. This role enables compliant innovation, drives continuous improvement, and ensures an effective Quality Management System supporting the site's responsibilities as an FDA-registered Specification Developer.
Compensation
The salary range estimated for this position based in Connecticut is $103,100.00–$150,000.00.
Responsibilities
Own the effectiveness of the site's Quality Management System, establishing priorities, balancing strategic initiatives with operational support, and ensuring compliance with applicable regulatory and corporate quality requirements.
Serve as the site's Management Representative, leading Management Review activities and communicating the health, performance, and effectiveness of the Quality Management System through meaningful quality metrics.
Provide strategic Quality leadership across the product lifecycle, from product development through commercialization and post-launch support.
Leverage quality system, product performance, customer feedback, complaint trends, and post-market data to identify emerging risks, drive systemic improvements, and influence product and process decisions across the product lifecycle.
Partner with Global Design Quality, Manufacturing, Supplier Quality, Regulatory Affairs, and cross-functional teams to ensure the site fulfills its responsibilities as an FDA-registered Specification Developer.
Requirements
Principal Systems Engineer - Robotics Capital & Instrument Performance - Surgical
Lead systems engineering for Robotics Capital & instrument performance within next-generation medical devices and robotic applications.
Compensation
Pay range / Rango salarial / Intervalo salarial /Fascia retributiva / Tranche de salaire / Gehaltsband / Salaribereik: Ireland: 81,120.00 EUR - 121,680.00 EUR | The final salary within this range will be determined based on objective, job-related criteria, including relevant experience, skills and qualifications, in accordance with our compensation framework.
Responsibilities
Lead systems engineering for instrument performance from stakeholder needs and product requirements through architecture, integration and verification.
Translate instrument and procedure needs into measurable system, subsystem and interface requirements with clear acceptance criteria.
Develop and maintain performance budgets for accuracy, force, torque, motion, latency and reliability across instruments, capital equipment and controls.
Own bidirectional traceability between requirements, risk controls, test methods and verification evidence.
Define system boundaries and interfaces between instruments, capital platforms, sensing, actuation, software and controls.
Requirements
Bachelor's in Systems Engineering or related engineering discipline
Master's/advanced degree in related engineering discipline
Nice to have: Medical-device experience
Nice to have: Surgical-robotics experience
Nice to have: Precision-instrumentation experience
B.S. degree from an ABET-accredited school in Mechanical Engineering, Mechanical Engineering Technology, Biomedical Engineering, Bioengineering, Biomedical Engineering Technology, Bioengineering Technology, Aerospace Engineering or Aeronautical Engineering
Product Security Representative (PSR) - AI COENewLifelancer · Remote
Principal Quality EngineerNewTwenty-Six Defense · Fort Worth, US