- Design Change regulations and internal policies.
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:
Provide continuing product support for manufacturing, regulatory and quality on design requirements, customer needs, testing, CAPA, reliability predictions, and product documentation
Product Design Support - Serviceability:
Assist the engineering team on implementing test plans, design analysis, making design adjustments, running performance calculations, and maintaining quality standards
Supply Continuity:
Support of the Engineering Change Order (ECO) process per Design Controls
Provide continuing product support for manufacturing, regulatory and quality on design requirements, customer needs, testing, CAPA, reliability predictions, and product documentation.
Service Methods:
Develop and implement continuous improvement against current service methodologies
Compliance:
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
Knowledge and Skills:
FDA Design Controls and EU Medical Device Directive (CE Marking requirements). PreferredHigh level of experience with system level requirements definition. PreferredPCB Design and Analysis experience and understanding, grounding / EMI considerations. PreferredUnderstanding of Ultrasound. PreferredKnowledge and experience with field service. PreferredExcellent project management skills. PreferredKnowledge and understanding of RF circuitry. PreferredPrevious experience in field service or service operations. PreferredFamiliarity with coding in C / C++ or other high-level programming language.
RequiredTest of electro-mechanical and/or electrical system in a production environment Ability to articulate complex ideas to technical and non-technical personnel.
RequiredEducation:
Bachelor's in electrical engineering or relevant engineering discipline. RequiredMaster's in electrical engineering.
PreferredExperience:
3-5 years employee experience. Preferred3-5 years of related design / development or service experience in the medical device and/or component.
PreferredBenefits:
Comprehensive Medical, Dental, and Vision plans20 days of Paid Time Off15 paid holidaysPaid Sick LeavePaid Parental Leave401(k)Employee bonusesAnd moreYour benefits and PTO start the date you're hired with no waiting periodCome join a company that is committed to being a trusted partner focused on our customers while not forgetting about our employeesEqual Opportunity Employer/Protected Veterans/Individuals with DisabilitiesThe 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)