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Sr Mechanical Engineer in Arden Hills, MN at Apex Life Sciences

Date Posted: 12/15/2018

Job Snapshot

Job Description


Sr Mechanical Engineer

Arden Hills, MN

For Immediate consideration please contact: jskiba@apexlifesciences.com

Job Description:

Develop and sustain mechanical components and designs of electronic medical equipment. Independently or as a member of a team develops and executes specifications, designs, plans and builds for newly designed or modified regulated Class II and Class III medical products.

Key Responsibilities

1. As the mechanical engineer, participates in and successfully contributes to project teams to typically including the following activities: designs mechanical sub-systems and specifies components,, develop clear specifications, evaluate feasibility of concepts, provide formal estimates, plan and execute testing, and prepare reports.

2. Works independently to plan and schedule own activities necessary to meet timelines.

3. Creates designs utilizing the departments’ standard development tools, procedures, and practices.

4. Designs, procures, and fabricates tooling and fixtures.

5. Performs troubleshooting on new products/process problems as related to design, material, or process.

6. Complete project deliverables and monitor project schedule and scope changes to assure team can meet delivery requirements.

7. Prepares standard reports/documentation to communicate status and results

8. Initiates and champions functional best practices and process improvements.

9. Influences and defines functional, departmental and divisional procedures through involvement with cross-functional engineering initiatives.

10. Coordinates cross-functionally with many functions such as: project management, electrical, software, buyers, quality, and regulatory.

11. Coordinates externally with test labs, suppliers, manufacturing sites, buyers, and contract design services.

Quality Systems Duties and Responsibilities:

Build Quality into all aspects of their work by maintaining compliance to all quality requirements.

Qualifications

- Mechanical Engineering degree, 5-7 year’s experience

Requirements (experience/skills):

- Able to read and write fluently in English.

- Experience working within a quality management systems: ISO 13485, Quality System Regulation 21 CFR 820 and Medical Device Directive.

- Experience with Pro/Engineer or Solidworks.

- Proficient in Microsoft Office applications.

Desired Experience/Skills:

- Experience with mechanical/environmental requirements in 60601-1

- Experience planning, executing, and reporting on environmental, mechanical, thermal, and reliability testing

- Experience with product lifecycle management applications such as Windchill.

Competencies for Success:

- Good interpersonal skills ability to interact with engineers, program managers, and regulatory staff members.

- Strong oral and written communication skills.

- Good organization and ability to multi-task.

- Strong attention to detail.

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178.




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