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    Mechanical Engineer II, III - Longmont, United States - Osypka Medtec Inc.

    Osypka Medtec Inc.
    Osypka Medtec Inc. Longmont, United States

    2 weeks ago

    Default job background
    Upper Management / Consulting
    Description

    As a Mechanical Engineer II or III, you will play a crucial role in the development and manufacturing of Class III medical devices. You will be responsible for executing mechanical engineering activities, from development to design verification and validation, to ensure the successful launch of new products for our clients.

    Organizational Competencies & Cultural Values:

    The mission of every employee at Osypka Medtec is dedication to serving, supporting, and improving the lives of our patients and customers by adding value through innovative quality medical devices and services.

    Our vision is to be a leading medical company in the development, production, sale, and marketing of permanent and temporary devices and services around the world.

    General Competencies:

    · Technical knowledge of mechanical engineering principles including proficiency in CAD software, specifically SolidWorks, prototyping, tolerance analysis, and material selection.

    · Knowledge of the strict regulatory guidelines and standards involved in developing and manufacturing class III medical devices.

    · Project management skills, including planning, coordinating, and resourcing tasks amongst cross-functional teams.

    · Problem-solving and troubleshooting ability to quickly propose effective solutions to technical problems.

    · Strong communication skills are critical in this role to present technical information to non-technical stakeholders, teams, and clients.

    · Continuous learning and adaptability to stay updated on industry trends and advancements to drive innovation in product development and streamline manufacturing processes.

    All employees are expected to provide customer service, communicate in an effective manner both verbally and in writing, display professionalism and integrity, as well as work efficiently, effectively, and accurately. Employees should take initiative, solve problems, display good judgment, and take ownership for delivering a high-quality product or service.

    Essential Job Functions:


    • Working in partnership with project manager and the quality team, manage the daily execution of tasks related to specific device development and manufacturing projects.


    • Working within the Quality Management System, and in partnership with key quality team members, update and maintain the Design History File (DHF) for device development projects.


    • Initiate and execute the design reviews and documentation for the DHF, including process validation, design verification protocols, and testing.


    • Sustaining engineering support for manufacturing, following company and regulatory requirements.


    • Conduct detailed engineering analysis and design calculations to support product development and continuous improvement in manufacturing.


    • Collaborate with cross-functional teams, including Engineering, Production, and Quality, to ensure the successful implementation of product design, development, and manufacturing.


    • Develop and review engineering drawings, specifications, and procedures to ensure compliance with regulatory requirements.


    • Participate in design verification and validation activities to ensure product safety, efficacy, and reliability.


    • Identify and troubleshoot technical issues during the development process and provide timely solutions.


    • Participate in risk management activities, such as FMEAs, to identify and mitigate potential risks to product performance.


    • Support the transfer of products from development to manufacturing, including the creation of manufacturing documentation and processes.

    Education and Experience:


    • Bachelor's degree in mechanical engineering or a related field.


    • Minimum of 3-5 years of experience in mechanical design and development, preferably in the medical device industry.


    • Strong technical writing skills.


    • Knowledge of design control processes, particularly in relation to medical devices (ISO 13485:2016, FDA regulations) preferred.


    • Experience with SolidWorks or other CAD software such as CREO.


    • Experience with engineering analyses, including tolerance analysis, finite element analysis, and failure mode and effects analysis.


    • Familiarity with manufacturing processes and assembly.


    • Excellent teamwork, communication, and project management skills.


    • Experience with design for manufacturability and design for reliability principles.


    • Experience with design verification and validation, including the use of statistical analysis.


    • Ability to work in a fast-paced and dynamic environment.

    Physical Demands:


    • Ability to work under stereo microscope, building miniature assemblies.


    • Ability to tolerate filter laser light/flashing lights and high magnetic fields.


    • Ability to sit or stand for long periods of time.


    • Ability to lift, bend or move up to 50 pounds.


    • Ability to adjust work schedule to meet deadlines and deliverables.

    Compensation:

    • $95,000 to $118,000 Annually, depending upon experience
    • Paid Vacation
    • Paid Holidays
    • Paid Sick Leave
    • Partial Payment by Company of Group Health, Dental, and Vision Insurance
    • 401(k) with limited company matching
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