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Senior Manager Software Engineering

Boston Scientific Corporation

Arden Hills, Minnesota, USA

Full-time

Innovation - Diversity - Caring - Global Collaboration - Winning Spirit - High Performance At Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we'll help you in advancing your skills and career. Here, you'll be supported in progressing - whatever your ambitions. Senior Software M

Senior Staff Mechanical Engineer, R&D - NPD

Stryker

Portage, Michigan, USA

Full-time

Work Flexibility: Hybrid As a Senior Staff Mechanical Engineer on Stryker's Neurosurgical New Product Development team, you will play a key role in designing and developing innovative medical devices that enhance patient care globally. This position supports the Integrated Systems & Smart Accessories team within the Neurosurgical business unit, focusing on the development of Stryker's next-generation Highspeed Drill Platform. You'll be involved throughout the entire product development cycle-fr

Senior Mechanical Design Engineer

Flextronics

Littleton, Massachusetts, USA

Full-time

Job Posting Start Date 07-23-2025 Job Posting End Date 07-28-2025 Flex is the diversified manufacturing partner of choice that helps market-leading brands design, build and deliver innovative products that improve the world. A career at Flex offers the opportunity to make a difference and invest in your growth in a respectful, inclusive, and collaborative environment. If you are excited about a role but don't meet every bullet point, we encourage you to apply and join us to create the extraord

Sr Mechanical Engineer

Flextronics

Littleton, Massachusetts, USA

Full-time

Job Posting Start Date 05-20-2025 Job Posting End Date Flex is the diversified manufacturing partner of choice that helps market-leading brands design, build and deliver innovative products that improve the world. A career at Flex offers the opportunity to make a difference and invest in your growth in a respectful, inclusive, and collaborative environment. If you are excited about a role but don't meet every bullet point, we encourage you to apply and join us to create the extraordinary. Job

Validation Engineer III

Katalyst Healthcares and Lifesciences

Mounds View, Minnesota, USA

Full-time

Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Perform, oversee, and guide supplier process validations (IQ/OQ/PQ) for sterile barrier packaging material manufacturing processes. Ensure supplier process validation requirements (CTQs, drawings, specifications, risk levels, and protocols) are communicated, understood, and executed. Collaborate with suppliers to review and approve validation documentation, including prot

Engineering Documentation Expert

Katalyst Healthcares and Lifesciences

Fort Worth, Texas, USA

Full-time

Responsibilities: Develop comprehensive technical documentation, including user manuals, installation guides, labeling materials, and regulatory documentation for ophthalmic devices. Work closely with engineering, regulatory, and quality teams to ensure all documentation meets industry standards and regulatory requirements. Interpret engineering drawings and specifications to create detailed build and qualification procedures for complex ophthalmic systems. Collaborate with R&D and manufacturing

CSV Engineer

Katalyst Healthcares and Lifesciences

Jacksonville, Florida, USA

Full-time

Responsibilities: Lead computer software validation (CSV) project planning activities including the creation or updates to URS, SDS and RTM documents. Create, review and approve software validation documentation. Create and execute qualification protocols and document reports; review and approve software test scripts and code reviews. Review and approve internal and vendor software packages and test documentation. Prioritize and plan all assigned projects for the software validation department.

Sr. Validation Engineer (CSV)

Katalyst Healthcares and Lifesciences

California, USA

Full-time

Responsibilities: Creates Computer System Validation (CSV) deliverables (Validation Plan, Requirements Specifications, Protocols, Summary Reports, Trace Matrices, SOPs, Risk assessments). Collaborates with Business Users, System Owner, Global IT teams and Business Analysts to define validation requirements and plans. Providing leadership, oversight, and training related to validation activities to multi-functional teams. Generate and execute validation protocols (IQ/OQ/PQ) using Good Documentati

Validation Engineer

Katalyst Healthcares and Lifesciences

Oceanside, California, USA

Full-time

Responsibilities: Lead or support cleaning, equipment, utilities, sterilization and/or autoclave qualification due to equipment modifications for tech transfers, Make-Assess-Release (MAR) or routine re-qualification activities. Ensure the timely completion of Cleaning Monitoring as well as validation team assignments. Any deviations, anomalies or schedule impacting items are to be reported to site management. This position provides trained technical resources for the development and executio

Senior Systems and V/V Engineer

Katalyst Healthcares and Lifesciences

Batesville, Indiana, USA

Full-time

Responsibilities: Your Role at Client This is where your work saves lives As part of an R&D project team, the Senior Systems and V/V engineer provides technical contributions to the system design and Verification/Validation of a complex medical device from concept through commercialization and/or through the full life cycle of the product. A senior engineer focuses on defining the customer needs; creating or modifying product system requirements and architecture necessary to meet those needs; e

Sr. Engineer Disposables R&D, Sustaining

Katalyst Healthcares and Lifesciences

Plymouth, Minnesota, USA

Full-time

Responsibilities: This section contains a list of primary responsibilities of this role that account for 5% or more of the work. The incumbent will perform other duties assigned. Lead and support small to medium sized projects with global cross-functional teams in the implementation of design changes (e.g. new features, suppliers, materials, labeling, CAPA/Client, cost reduction, remediation). Identify, investigate, and solve engineering problems utilizing risk-based and customer focused app

Wifi Software Engineer

Katalyst Healthcares and Lifesciences

Skaneateles, New York, USA

Full-time

Responsibilities: Design and implement portions of the software for new and existing devices, working cross functionally to understand needs and requirements, and supporting the team with your technical expertise. Take part in the creation of schedules and tasking to facilitate the execution of development, completion, and delivery of software. Apply strong software engineering expertise to design and implement robust software architectures, while influencing the processes and methodologies u

Automation Control Engineer

Katalyst Healthcares and Lifesciences

South Plainfield, New Jersey, USA

Full-time

Responsibilities: Support design reviews, debugging, acceptance, and validation of equipment developed by external suppliers. Assist in decommissioning and recommissioning of equipment to ensure proper functionality and compliance. Conduct and analyze Gauge Repeatability & Reproducibility (GR&R) studies and Process Capability assessments. Work with automation control systems, including PLCs, HMIs, Vision Systems, Servos, and Robots. Develop and optimize programs for Allen-Bradley/Rockwell Automa

Regulatory Affairs Project Manager

Abbott Laboratories

Los Angeles, California, USA

Full-time

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries. Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the s

Process Engineer

Katalyst Healthcares and Lifesciences

Dublin, California, USA

Full-time

Job Summary: We are seeking a skilled and detail-oriented Process Engineer with an electrical or mechanical engineering background to join our team. The successful candidate will be responsible for overseeing the transfer of medical device manufacturing processes from one facility to another, ensuring seamless operation, compliance with regulatory standards, and minimal disruption to production schedules. Responsibilities: Design History File: Ensure that the transferred process is adhering to t

LabVIEW/TestStand Engineer

Webilent Technology, Inc.

Texas, USA

Full-time, Part-time, Contract, Third Party

Webilent is a leading business technology solutions company. We specialize is providing turn-key project execution as well as employee augmentation services. We strive to be the IT partner of choice for every client we serve. We value the role every individual plays in helping our clients meet their end-goal objectives while maintaining the highest level of commitment to our core values: integrity, expertise and service excellence. We give clients the freedom to reach their goals through a varie

Sr. Principal Software Quality Engineer

Katalyst Healthcares and Lifesciences

Bellevue, Washington, USA

Full-time

Responsibilities: Partner with development teams to ensure compliance with FDA, ISO 13485, IEC 62304, ISO 14971, and cybersecurity standards. Provide quality oversight for Design History Files (DHF), risk management, V&V, and design controls. Lead software risk management (RMF), including risk evaluation, control, and mitigation. Drive Secure Product Development Framework (SPDF) and software security best practices. Support Agile software development teams, ensuring regulatory and quality compli

Principal R&D Engineer

Katalyst Healthcares and Lifesciences

Plymouth, Minnesota, USA

Full-time

Job Description: This section focuses on the main purpose of the job in one to four sentences. Leads design and development of product changes within sustaining engineering for disposable medical devices. Responsibilities: This section contains a list of primary responsibilities of this role that account for 5% or more of the work. The incumbent will perform other duties assigned. Schedule, budget, and lead engineering projects with minimal guidance. Serve as the technical expert for design

R&D Engineer

Katalyst Healthcares and Lifesciences

Santa Rosa, California, USA

Full-time

Roles and Responsibilities: Prepare test protocols and completion reports. Conduct testing in the lab, understand flow of events and need-by timelines, coordinate and communicate with all parties and mitigate any problems that arise. Perform test method and fixture updates including test method validation and equipment IQs etc. Responsible for Initiating Build Requests with the manufacturing team. Knowledge about tensile strength testing, fatigue testing, pressure testing, torque testing et

Process Engineer

Katalyst Healthcares and Lifesciences

Dublin, California, USA

Full-time

Job Summary: We are seeking a skilled and detail-oriented Process Engineer with an electrical or mechanical engineering background to join our team. The successful candidate will be responsible for overseeing the transfer of medical device manufacturing processes from one facility to another, ensuring seamless operation, compliance with regulatory standards, and minimal disruption to production schedules.Key Responsibilities: Design History File: Ensure that the transferred process is adhering t