Engineering Manager/Production Engineering Manager (on-site)

Sigmastim Domestic LLC

Engineering Manager/Production Engineering Manager (on-site)

Tualatin, OR
Full Time
Paid
  • Responsibilities

    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