Posted: 15 June
The role
Embedded Software Systems Engineer R&D
We are seeking a System Architect to lead system‑level design and technical direction for complex medical electronic systems with a strong embedded software and firmware component. The role involves defining system and software architecture, guiding cross‑functional engineering teams, and ensuring delivery of safe, compliant, and high‑performing medical device platforms under global medical device standards and regulations such as IEC 60601, ISO 14971, and ISO 13485.
Key Responsibilities
Lead or mentor technical teams in the design and development of components, sub‑systems, and systems for medical devices.
Apply and mentor on advanced engineering theories, principles, and concepts across various products.
Assess and integrate new technologies and capabilities (prototyping, testing, etc.) for the organization.
Mentor and influence resolution of complex product design issues.
Generate and review project documentation including requirements, design, architecture, bugs, and test plans.
Define and govern system and embedded software architecture.
Translate product and user requirements into system, software, and subsystem specifications.
Lead system and software architecture and design reviews.
Navigate and influence intellectual property strategy for filings and protection.
Develop invention disclosures, patents, or trade secrets.
Guide architecture of complex systems and make design trade‑off decisions.
Lead and support code reviews applying design principles, coding standards, and best practices.
Collaborate on financial/business modeling and support business reviews to validate a technical approach.
Lead cooperative efforts with R&D, Quality, Manufacturing, Regulatory, Clinical, Marketing, and Project Management to ensure project success.
Implement design and process solutions, ensuring long‑term sustainability.
Develop and utilize tools to enhance product/process development or performance.
Mentor and grow technical talent within discipline/function.
Serve as a liaison between technical and business teams, building relationships across the organization.
Maintain independent oversight of engineering documentation and processes.
Business Responsibilities
In-depth knowledge of industry and competitive landscape.
Partner with customers and key opinion leaders to develop technical strategies that meet clinical needs.
Strategize and execute customer‑facing activities such as voice of customer and customer‑centric design.
Collaborate on financial and business modeling and support business reviews.
Medical Device Compliance
Expertise in applying industry standards in device development.
Independent reviewer and advisor for engineering documentation, such as the Design History file.
Lead development of standards and regulations, working closely with cross‑functional teams.
Technical Skills
Lead system software implementation using embedded software development skills.
Design and Development Skills
Lead strategies for integrated development environments (IDEs) and toolchains.
Lead strategies for static/dynamic analysis, memory management, code coverage, and analysis techniques.
Lead strategies for integration and deployment in complex embedded or electronic system development.
Software Process Skills
Lead adoption of Software Development Life Cycle (SDLC) process changes and best practices.
Lead adoption of Application Lifecycle Management/Traceability best practices and tools.
Lead teams in creating estimates for code implementation, including time and resource planning.
Apply regulatory and compliance standards to SDLC.
Preferred Skills / Engineering Tools
System‑level and embedded software architecture experience.
Embedded firmware development in real‑time systems, microcontrollers, or SoCs.
Experience defining software architecture in safety‑critical or regulated environments.
Experience with medical device development under IEC 60601, ISO 14971, ISO 13485.
Experience delivering Class II or Class III medical devices to market.
Experience with IEC 62304 software lifecycle processes.
Experience supporting regulatory submissions and audits.
Background in RF, power electronics, or energy delivery systems.
Knowledge of cybersecurity requirements for connected medical devices.
Education Requirements
Bachelor’s degree in Electrical Engineering, Computer Engineering, Software Engineering, or related discipline.
Minimum 10 years of experience in complex embedded or electronic system development.
Project Engineer – Trauma R&D (Cork)
Support the development of next‑generation orthopaedic trauma products in a fast‑paced, regulated environment. The role is suitable for early‑career engineers who enjoy technical ownership and cross‑functional collaboration.
Key Responsibilities
Support NPI projects within the Trauma portfolio, contributing at component, sub‑system, or system level.
Model, detail, and develop mechanical designs for implants, instruments, packaging, and related components using CAD tools.
Develop and support prototypes for design verification, validation, and risk reduction.
Own defined project workstreams or technical deliverables, ensuring alignment with performance, quality, cost, and timeline expectations.
Support and execute product development through the design control process, in compliance with internal procedures and regulatory requirements.
Participate in design reviews, risk management activities, and structured problem‑solving.
Collaborate closely with Design, Manufacturing, Quality, Regulatory, Packaging, PMO, and suppliers to deliver robust and manufacturable solutions.
Engage with Health Care Professionals to gather clinical input for design, evaluation, and refinement of new products.
Build understanding of surgical procedures and clinical workflows to develop user‑focused solutions.
Mentor and develop junior team members through technical guidance.
Qualifications
Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or related field.
Early‑career engineering candidates; experience through internships, placements, or industry roles in R&D or regulated environments is strongly valued.
Fundamental knowledge of mechanical engineering principles, design practices, and development processes.
Basic experience with CAD tools and design concept generation.
Basic understanding of materials, manufacturing methods, and tolerance considerations.
Knowledge of analysis tools and statistical methods.
Ability to read and interpret complex engineering drawings and technical documentation.
Ability to manage multiple tasks across projects while maintaining attention to detail.
Strong communication skills and comfort working in a cross‑functional, international team.
Proactive mindset with willingness to take ownership, learn quickly, and grow technical responsibility.
Senior Project Engineer – Advanced Operations
Role summary: Design, validate, and bring new products to market while ensuring compliance with manufacturing and regulatory requirements. Responsible for product specifications, testing, and process validation plans.
Key Responsibilities
Provide engineering support for new product and process introductions, ensuring all activities are documented in accordance with Stryker development procedures.
Project manage introduction of new capital equipment and support qualification and validation activities.
Evaluate and optimize process layouts for manufacturability and quality.
Assist in selection of components and equipment based on reliability and regulatory requirements.
Develop specific testing and inspection protocols in collaboration with quality engineers.
Support capital acquisition activities.
Participate in PFMEA, Control Plan, SOP, and PPAP generation for product transfers and launches.
Conduct MSA studies for new products and processes.
Provide training for manufacturing team members.
Ensure adherence to GMP and safety procedures.
Review and approve validation documentation.
Qualifications
B.S. in Mechanical Engineering or related discipline with 2+ years of experience.
Self‑starter with efficient work methods, analytical and problem‑solving skills, and ability to handle multiple tasks in a fast‑paced environment.
Excellent interpersonal skills and ability to collaborate with multidisciplinary teams.
Innovative thinker with the ability to envision new ways of working.
Excellent analytical skills and ability to plan, organize, and implement concurrent tasks.
Knowledge of manufacturing processes, materials, and product and process design.
Proficiency in reading and interpreting complex engineering drawings and tolerancing.
Experience in an FDA‑regulated or regulated industry is beneficial.
Excellent attention to detail.
Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.
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