Description: Systems Engineering is an engineering discipline focused on creating and executing an interdisciplinary process to ensure that the customer and stakeholder's needs are satisfied in a high quality, trustworthy, cost-efficient and schedule-compliant manner throughout a system's entire life cycle. The Senior Systems Engineer will lead system definition / development activities in one or more MNK medical device development projects, and act as a contributor to other projects.
Essential Functions:
1. Understands the intent, constraints and value proposition of a given project. Aligns system engineering activities to meet these.
2. Acquires expertise in existing device performance and behaviour to guide lifecycle management projects.
3. Conceptualizes complete solutions. Creates or coordinates the design solutions for novel or complex problems.
4. Creates and assesses system architecture options with cross-functional (electrical / mechanical / SW) team to define optimal system solution.
5. Works with program core team members including Software, Electrical and Mechanical engineering along with Quality and Regulatory to ensure conformance to established design development processes and procedures.
6. Translates User Needs (from multiple internal and external stakeholders) into verifiable technical design requirements.
7. Decomposes system requirements to subsystem requirements (including SW), ensuring functional coverage.
8. Executes work under MNK’s design controls process and in compliance with the company’s quality management system.
9. Works with program managers to help create project schedules. Leads and facilitates architectural and design decisions to ensure on-time delivery of projects. Escalates technical issues in a timely fashion to Systems Engineering leadership.
10. Works with multiple internal stakeholder groups (Verification, Validation, Quality, Commercial, Clinical, Regulatory Affairs etc.) to resolve system definition challenges.
11. Assesses and clearly communicates technical status of projects.
Education / Experience / Skills:
1. BS or MS degree in a scientific or engineering discipline.
2. 5+ years Systems Engineering experience in complex electro-mechanical products.
3. 3+ years medical device development experience.
4. Applied knowledge of medical device regulations and standards (e.g., FDA 21 CFR Part 820, ISO 13485:2016, ISO 14971:2019, IEC 60601, IEC 62304 etc.).
5. Familiarity with requirements management tools (e.g., DOORS, Polarion, Jama), as well as modelling-based systems engineering tools (e.g., Enterprise Architect, IBM Rhapsody) preferable.
6. Self-starting, motivated individual who takes ownership of their tasks.
7. Excellent written and verbal communication skills.
8. Functions well in a team environment. Gains consensus, leads, influences and ensures cross-discipline participation and feedback.
9. Familiarity with requirements management tools (e.g., Jama Connect), as well as model-based systems engineering tools (e.g., Enterprise Architect) preferable.
Working Conditions:
Office based role, with opportunity for hybrid work.
Skills:
systems design, systems engineering, medical device, design development, engineering, electrical, firmware, electrical engineering, system integration.
Employee Value Proposition:
Longevity on project chance to develop.
Job Title:
Senior Systems Engineer
Location:
Dublin, Ireland
Job Type:
Contract Trading as Aerotek.
Allegis Group Limited, Maxis 2, Western Road, Bracknell, RG12 1RT, United Kingdom.
No. 2876353. Allegis Group Limited operates as an Employment Business and Employment Agency as set out in the Conduct of Employment Agencies and Employment Businesses Regulations 2003. Aerotek and Actalent Services are companies within the Allegis Group network of companies (collectively referred to as "Allegis Group"). Aerotek, Actalent Services, Aston Carter, EASi, Talentis Solutions, TEKsystems, Stamford Consultants and The Stamford Group are Allegis Group brands.
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