Senior Systems Engineer (on-site in Durham, NC or Chicago)
Gilero is a leading medical device design, development, and manufacturing partner. We specialize in creating innovative solutions that improve patient care and enhance lives. Our growing dynamic team of professionals works across disciplines to bring ideas to life, from concept to commercialization.
We are seeking a highly skilled Senior Systems Engineer to lead and contribute to the development of complex medical devices and combination products. The ideal candidate will bring a systems-level perspective, integrating mechanical, electrical, and software components while ensuring compliance with regulatory and quality standards. You will be responsible for leading systems engineering project activities for medical device and drug delivery applications.
This role is pivotal in bridging engineering disciplines to deliver safe, effective, and innovative healthcare solutions.
Join us in a collaborative and innovative environment where your contributions will make a real difference. You'll work with multiple clients across a variety of cutting-edge products to help shape the future of healthcare technology, ensuring products meet the highest standards and positively impact patient outcomes across the globe.
Responsibilities:
- Acts as technical lead throughout the full product development lifecycle from initial concept to release to market of new medical devices; primarily class I and class II electro-mechanical devices.
- Provides expertise in various Systems Engineering principles including user and stakeholder need definition; requirements definition; risk management, product architecture, configuration management, traceability, change management, and reliability.
- Plans systems engineering projects by identifying appropriate system development lifecycles.
- Develops product development strategies for large or complex systems integrations.
- Generates system architecture definitions, integrations, development viewpoints, and models.
- Manages the system architecture and relates it to the design throughout the lifecycle.
- Defines requirements hierarchy and how it relates to verification and validation planning.
- Performs functional system decompositions to solve complex design challenges.
- Prepares detailed component and assembly drawings. Leads and participates in writing product and customer requirements, design and phase
- reviews, product and process risk assessments, root cause investigations, and corrective
- action planning.
- Plans, authors, and executes test methods and protocols for design verification and
- validation.
- Analyzes test data, interprets results, and formulates conclusions.
- Maintains the Design History File (DHF) and ensures documents are complete, accurate,
- current, and compliant with regulations.
- Contributes to developing systems engineering tools and processes and trains others to use
- those systems.
- Identifies technical opportunities and generates work for themselves within their assigned
- project teams.
- Defines objectives, participates in, and oversees the quality of output for large or complex
- projects.
- Contributes to solving open-ended problems and tasks with a high level of decision-making.
- Formulates and develops detailed project deliverables with some management oversight.
- Communicates technical risks and proposed solutions clearly and directly with the customer.
- Sources and interfaces with third-party vendors.
- Acts as subject matter expert (SME) lead in one or more areas and is aware of industry trends.
- Supports business development efforts as a SME to potential customers and providing input on engineering estimations.
- Establishes a proven track record of building trust and rapport with new clients.
- Acts as mentor demonstrating strong leadership skills.
- Participates in recruitment activities including interview panels.
- Travel will be required, as necessary (typically less than 5%).
Skills/Qualifications:
- U.S. Citizen or Green card holder.
- BS in Engineering or equivalent technical degree.
- Work onsite in Durham, NC or Chicago office.
- 5+ years relevant experience.
- Experience developing electro-mechanical medical devices.
- Proven ability to lead a product development program from concept to market release.
- Working knowledge of system modeling tools and methodologies (e.g., UML, SysML).
- Working knowledge of working in both agile and waterfall methodologies.
- Proficiency with SolidWorks or other 3D CAD (Computer Aided Design) modeling software.
- Working knowledge of requirements management software (e.g., Jama, Polarion, Doors).
- Working knowledge of developing products for compliance with IEC 60601 for electrical
- safety and for software development.
- Working knowledge of developing products for compliance with FDA 21 CFR Part 820.30, 21.
- CFR Part 4, ISO14971, ISO 13485 and EU MDR.
Personal Attributes:
- Meets Gilero Core Values: Collaboration, Innovation, Excellence, Integrity.
- Productive in a fast-paced, entrepreneurial environment.
- Commits to excellence and quality service to external and internal customers.
- Adheres to established policies and procedures, while contributing to continuous improvements.
Why work at Gilero:
Founded in 2002, Gilero, a Sanner Group company, is an international contract engineering firm that specializes in the design, development, and manufacturing of novel medical devices and drug delivery products. We consider our employees to be our company’s greatest asset because it’s our people that make Gilero a great place to work and a great company to work with. Locations include NC locations in Raleigh, Durham, Greensboro, Pittsboro, as well as Chicago, IL, Carlsbad, CA, and Tijuana, Mexico. You will enjoy an annual bonus, Medical (3 BCBS plans to choose from), Guardian dental and vision, short-term and long-term disability, 401K with a 5% match the first month you start with a zero-vesting period.
