Senior Mechanical Engineer

Industry

Engineering

Advert ID

FOX_BBBH192909

Location

New Prague

Job Type

Permanent

Hours

Full-Time

Salary Range

USD120000-145000 per year

No. of Openings

1

Branch Information

Minnesota Engineering - (USA) 3600 Minnesota Drive Suite 850 MN Edina , MN 55435 Phone : 612-630-1200

ContactNumber

612-630-1200

Job Description

Manpower Engineering is partnering with a well-established medical device company dedicated to designing, manufacturing, and marketing innovative technologies that help patients around the world live healthier, more active and fulfilling lives.



The organization cultivates a culture of proud, driven employees who are passionate about the work they do. Leadership is dedicated to uncovering the unique potential in every individual, so you can have a direct impact on the future of technology and be provided with exciting opportunities for career growth.



Summary:



The Mechanical Engineering Manager has direct responsibility for standard product support and new product development as well as budgetary responsibility for the areas under their control. This role is responsible for day-to-day operations, identification and implementation of cost saving measures, and leading continuous improvement. You will manage and build a team that exhibits and shares the core values of the organization.



Responsibilities:



* Develop and execute project plans to support standard product and new product development. Including setting project plans, creating budgets and timelines, and communicating project updates to key stakeholders

* Lead, train, and mentor a team of Engineers.

* Ensure all Engineering activities in compliance with applicable FDA & international regulatory requirements.

* Develop and implement procedures and controls to promote communication and adequate information flow within Engineering and with outside stakeholders.

* Utilize Root Cause analysis and related tools to resolve CAPA's or other complex technical issues.

* Coordinate resources for Engineering in accordance with established policies, principles, and procedures.

* Build strong teams that are engaged, productive, informed, recognized, and held accountable.

* Drive industry leading technical expertise within engineering related to drawing creation, tolerance analysis, critical dimensions and capability, product performance and life testing.



Qualifications:



* Bachelor's degree in engineering, manufacturing, business or equivalent combination of education and experience.

* 7+ years of successful and progressive experience managing an engineering team within the medical device industry.

* Strong knowledge of ISO 13485, FDA, Total Quality Management and Six Sigma.

* Experience using risk management techniques consistent with ISO 14971/ISO 13485 to assess and mitigate risk associated with activities in new product committee, manufacturing changes, corrective and preventive action and other changes that impact product and/or process.

* Strong Project Management background including setting project plans, creating budgets and timelines, and communicating changes and progress inside and outside of the organization.

* Excellent leadership skills with the ability to motivate employees, inspire respect and trust, display passion and optimism, and mobilize teams to fulfill the organizational vision.



What's in it for YOU?



* Unlimited PTO

* Employee bonus plan

* Flexible hybrid/remote work options

* Full pay maternity, paternity, parental, short-term disability leaves

* Employee driven recognition program

* Company paid educational assistance

* Competitive health and welfare plans -HSA company contribution

* 401(k) company match