Spartronics is more than just a company. We have great facilities, a dedicated and talented team, tremendous capacity and capabilities, and longstanding customers who need us. Now, it’s all about driving forward with a winning strategy that builds on our strengths to create growth for our - customers, shareholders and employees. As an Electronic Manufacturing Services provider, we strive to meet and exceed our mission to be the preferred provider of fail-safe electronics solutions that save lives and protect what matters the most.
At Spartronics, we're not just building products, we build products lives depend on. As an electronic manufacturing services (EMS) provider for the commercial aerospace, defense, medical device, life science, and industrial markets, we work to deliver products of the highest quality and reliability.
Our organization provides comprehensive contract manufacturing services, ranging from printed circuit board assembly (PCBA) and subsystem integration to full-box build (high-level assemblies). We also offer value-added services from early-stage engineering support to manufacturing testing, design for excellence and sustaining engineering for the full product lifecycle. With over $500 million in revenue, approximately 1,700 dedicated employees, and manufacturing resources strategically located worldwide, our manufacturing network spans the United States, Mexico, and Vietnam. To learn more about our sites, please visit https://www.spartronics.com/locations.
Why Join Us:
When you become a part of Spartronics, you're joining a team of dedicated and talented individuals who share a common goal - to win as one. We value talent, innovation, and a hunger for growth. Here, you'll have the opportunity to work with industry leaders in Aerospace & Defense, Medical & Life Science, and Industrial markets where our customers put full trust in us to deliver the most complex, highly regulated products that have to work the first time, every time.
About the Role:
As a Sr. Systems Engineer at Spartronics, you'll play a pivotal role in the design engineering team with technical responsibility for the specification, verification, and risk management of new products in compliance with the ISO-13485 standard. Your contributions will help us continue our journey towards Winning as One: One company. One team. One purpose. One plan. One culture.
Location: Strongsville, OH
Key Responsibilities:
Develop requirements and architectures for medical devices and other complex products in collaboration with project teams.
Analyze standards for applicability to specific devices or systems.
Lead Risk Management activities including planning, hazard analysis, risk mitigations, essential performance, and reporting.
Perform Fault Tree Analysis and Failure Mode Effects and Critical Analysis.
Lead design verification and validation phase activities.
Develop and maintain trace matrices to demonstrate trackability of verification testing and risk mitigations to design input.
Author verification plans, protocols and reports for complete systems and sub-systems.
Facilitate review of products with regulatory agencies for compliance to industry standards.
Lead and perform reliability engineering tasks to evaluate design life.
Develop manufacturing final test requirements and process.
Maintain Design History Files throughout the development process.
Compile Technical File contents to support regulatory submissions.
Requirements
The Experience we are looking for to add to the Team:
Bachelor's degree in engineering or science related field – biomedical engineering preferred.
Minimum 8 years systems engineering experience or role having overall systems compliance responsibility involving electrical (analog and digital), mechanical and firmware disciplines.
Experience with medical, or other regulated industry, product development.
Experience developing and executing verification protocols for medical devices.
Knowledge, Skills & Abilities:
Knowledge of product development processes and best practices.
Thorough understanding of ISO 13485, FDA medical device regulations and design control processes.
Ability to build and maintain effective cross functional and cross organization relationships.
Effective communication skills driven by attention to detail.
Strong DFM and NPI skills.
Good working knowledge of quality/reliability engineering statistical techniques.
Self-motivated and self-managed.
Ability to handle multiple projects at the same time.
Our Commitment:
At Spartronics, we're dedicated to fostering an inclusive, diverse, and equitable workplace. We believe that diverse perspectives drive innovation, and we welcome candidates of all backgrounds to apply. Our culture at Spartronics values accountability, unity, respect, and transparency. These winning values are the lifeblood of our business. We embrace diversity through people who believe in these values. Embracing our employees’ differences enables us to be a stronger team.
Join Our Journey:
If you're ready to be a part of something extraordinary, challenge the status quo, and shape the future, then we want to hear from you. Together, we'll continue to win, while we build products lives depend on.
Our Benefits:
Full range range of medical, dental, and vision benefits. Medical plan options include 2 PPO plans and 1 High Deductible Health Plan (HDHP) with a Health Savings Account (HSA). By completing an annual Biometric Screening, you will save $ on your PPO plan. On the HDHP, we contribute $1,500 to your HSA.
Flexible Spending Savings Accounts for Medical, Dependent Care, and Limited Purpose (dental and vision only).
PTO and Holiday Pay
Company-paid life insurance and disability at 1 times your annual salary at no cost to you, with options to increase coverage amounts.
401k with a company match of 50% to every dollar up to 6%.
Accident, Critical Illness, Hospital Indemnity, and Legal Insurance optional plans.
Employee Assistance Program
Tuition Reimbursement
Opportunities to grow and excel at a company that values promotions and learning from within. Every day is different, challenging, and rewarding.
How to Apply:
If this sounds like the perfect opportunity for you, please apply with your resume and a cover letter outlining your qualifications and why you're excited about joining Spartronics.
Spartronics is an equal opportunity Employer/Veteran/Disabled 41 CFR 60-1.4. We comply with federal Affirmative Action guidelines in all employment opportunities for qualified employees and applicants. We encourage applications from candidates of all backgrounds and experiences.
