Engineering Manager/Production Engineering Manager (on-site)
Benefits:
Bonus based on performance
Company parties
Competitive salary
Dental insurance
Donation matching
Health insurance
Paid time off
Vision insurance
Wellness resources
SigmaStim is a small medical electronics company that has been in business for 45 years. We an excellent working environment that prioritizes work-life balance. We attract high-level talent who are able to manage themselves and have superior experience and expertise. This is a position for someone who enjoys to staying busy with research and development and troubleshooting projects. There is rarely a dull moment, and our team encourages a large amount of collaboration so this is an on-site engineering position.
REQUIRED COMPETENCIES / SKILLS:
· Bachelor of Science degree in an engineering discipline or applicable college studies along with at least five years of relevant job experience
· Direct responsibility for engineering projects, design changes, upgrades, component selection, and associated documentation
· Analog and digital electrical circuit design experience
· Oversee creation and maintenance of electrical schematics, Printed Circuit Board (PCB) layout files, and mechanical/assembly drawings using Computer Aided Design (CAD) tools
· Create, execute, and maintain test protocols for devices, subassemblies, accessories, and in-house test and measurement equipment.
· Accountable for test and measurement equipment calibration and verification utilized by the engineering, production, and service teams.
· Manage, monitor, and document production processes to ensure regulatory compliance and continuous improvement
· Function as the principal point of contact for resolving production process challenges and personnel matters
· Ability and knowledge to help the production and service team troubleshoot challenging device failures
· Some level of coding skills to help with the development of code
PREFERRED COMPETENCIES / SKILLS:
· Knowledge of ISO 13485, MDSAP, FDA, EU MDR regulations, and IEC 60601 collateral electrical standards
· Knowledge of REACH and RoHS EU Regulations
· Medical device manufacturing experience
· Experience in risk management and analysis (ISO 14971)
· Knowledge of design optimization for manufacturability and design transfer to production
· Component‑level troubleshooting of PCB assemblies to resolve technical issues
· Provide and document customer support through phone, email, and video conferencing, ensuring clear communication and long‑term reliability; escalate and notify executive management when necessary to address critical issues
ADDITIONAL COMPETENCIES / SKILLS (Not required):
· Printed Circuit Board PCB layout experience
· Mechanical component design experience using CAD tools
· Firmware and embedded systems software development utilizing C, C++, and Assembly languages
· REACH & RoHS regulation knowledge and experience setting up maintenance system
· Execute medical device manufacturing tasks including assembly, quality assurance, testing, and rework of subassemblies and finished devices