- Provide continuing product support for manufacturing, regulatory and quality on design requirements, customer needs, testing, CAPA, reliability predictions, and product documentation.
- Assist the engineering team on implementing test plans, design analysis, making design adjustments, running performance calculations, and maintaining quality standards.
- Support of the Engineering Change Order (ECO) process per Design Controls - Design Change regulations and internal policies.
- Provide continuing product support for manufacturing, regulatory and quality on design requirements, customer needs, testing, CAPA, reliability predictions, and product documentation.
- Develop and implement continuous improvement against current service methodologies.
- Ensure compliance to the requirements of ISO 13485 standards, FDA regulations and Good Manufacturing Processes regarding service and repair of new product launches and product upgrades.
- FDA Design Controls and EU Medical Device Directive (CE Marking requirements). Preferred
- High level of experience with system level requirements definition. Preferred
- PCB Design and Analysis experience and understanding, grounding / EMI considerations. Preferred
- Understanding of Ultrasound. Preferred
- Knowledge and experience with field service. Preferred
- Excellent project management skills. Preferred
- Knowledge and understanding of RF circuitry. Preferred
- Previous experience in field service or service operations. Preferred
- Familiarity with coding in C / C++ or other high-level programming language. Required
- Test of electro-mechanical and/or electrical system in a production environment Ability to articulate complex ideas to technical and non-technical personnel. Required
- Bachelor's in electrical engineering or relevant engineering discipline. Required
- Master's in electrical engineering. Preferred
- 3-5 years employee experience. Preferred
- 3-5 years of related design / development or service experience in the medical device and/or component. Preferred
- Comprehensive Medical, Dental, and Vision plans
- 20 days of Paid Time Off
- 15 paid holidays
- Paid Sick Leave
- Paid Parental Leave
- 401(k)
- Employee bonuses
- And more
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Sr. Biomedical Engineer - Racine, United States - Merz North America
Description
About the Company:Merz is a family-owned medical device and pharmaceutical company headquartered in Germany. Our Global Technical Operations based in WI manufactures, packages and ships several innovative products so that people all over the world can live better, feel better, and look better.
This role is to collaboratively partner with business leaders to ensure continuity of supply for MNA device business and optimize our technical service operation to meet the global customer demands.
Hybrid: Allows for up to two days of working from home and three days in the office, as per company policy.
Key Responsibility:
Installed Base Support:
Come join a company that is committed to being a trusted partner focused on our customers while not forgetting about our employees
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR c)
