Biomedical Engineer - Mechanical
Merz North America
Franksville, WI

About $66,000 - $93,000 a year

EducationSkills
Job Details
Description
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.

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 – 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.

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
Education

Bachelor in Mechanical Engineering or equivalent experience or relevant engineering discipline Required
Bachelor in Mechanical Engineering or equivalent experience or relevant engineering discipline
Professional experience

0-3 years ME experience -
0-3 years of related design / development or service experience in the medical device and/or component
Knowledge, skills and abilities (incl. languages)

FDA Design Controls and EU Medical Device Directive (CE Marking requirements)
Knowledge and experience with application of Six Sigma statistical analysis and controls
Understanding of Ultrasound
Knowledge and experience with field service
Knowledge of methods

Excellent project management skills Required
Previous experience in field service or service operations

Qualifications
Education
Required

Bachelors or better in Mechanical Engineering or related field.

Preferred

Masters or better in Mechanical Engineering.

Experience
Preferred

Less than 3 years: Related design / development or service experience in the medical device and/or component
Less than 3 years: Mechanical Engineer
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.