Manager, R&D Engineering - Oldsmar, FL

 

 

With a passion for life

 

Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers – and to save more lives, we need team players, forward thinkers, and game changers.

Are you looking for an inspiring career? You just found it.

 

 

Job Function Summary:

The Manager, R&D Engineering will besponsible for technical leadership and management of engineering employees and projects, which require engineering expertise.   Will lead a team of engineers to successful new product development in sterility assurance and infection control consumables.

 

The Manager, R&D Engineering will be responsible for the leadership of complex cross-functional projects related to the development and complete integration of Ultra Clean Systems technologies and engineering processes.

 

This position is an onsite role and will report to the site Managing Director.  This individual will participate in the design and development of electric products. 

 

Job Functions: 
•    Initiates design changes to improve product performance, reduce cost and enhance the manufacturability of commercially released medical devices.
•    Supports CAPAs, NCRs and Product Complaints by investigating and addressing potential product design issues as appropriate.
•    Maintains the Design History File (DHF) and Device Master Record (DMR) throughout the lifecycle of the product based on changes to the product design or manufacturing process.
•    Participates in Design Reviews to ensure adequacy of the design requirements and capability of the design to meet the requirements.
•    Works cross functionally on design changes, process improvement projects and quality/compliance initiatives.
•    Creates and executes protocols for Design Verification and Validation activities, engineering studies and feasibility studies.
•    Aids in the selection, design and evaluation of process and test equipment.
•    Creates protocols and reports for process validation, test method validation, equipment qualification and gage R&R studies.
•    Processes change orders to create or revise design input and output documentation.
•    Performs product testing and engineering studies.
•    Supports the development and revision of part specifications and other design documentation.
•    Mentors and develops the team.
•    Manages day-to-date activities of the team and assigns tasks based on priority.
•    Contributes to the team effort by accomplishing related tasks as needed.

 

Required Knowledge, Skills and Abilities: 
•    Demonstrated ability to solve technical challenges with cross-functional teams. 
•    Strong analytical, problem solving and communication skills.
•    Strong communication and collaboration skills.
•    Self-motivated, with the ability to accomplish project goals with minimal supervision.
•    Experience with Agile PLM and Minitab desired.
•    Knowledge of Good Documentation Practices (GDP) required.
•    Experience in communicating (both orally and written) to all levels of the organization.

 

Minimum Requirements:  
•    Bachelor’s degree in Engineering or scientific discipline, such as electrical or mechanical engineering.  
•    A minimum of four years’ experience in the medical device industry with relevant experience in design control, production and process controls and/or R&D or related areas.
•    A minimum of two years of management experience. 
•    Knowledge of 21 CFR Part 820 and standards relevant to medical devices.
•    Experience in leading projects or activities in groups.
•    Strong experience with Microsoft Office applications (Word/Excel/Power Point) is required.   

 

Quality Requirements:
•    Build Quality into all aspects of their work by maintaining compliance to all quality requirements.
•    Ensure compliance to all FDA and Worldwide Quality & Compliance regulations.
•    Must have the education and experience to understand and comply with U.S. and Worldwide medical device regulations.
•    Attend all required Quality & Compliance training at the specified interval.
•    Adopt the “Beyond Compliance Quality Culture” in the work environment; always meet and exceed requirements.

 

Environmental/Safety/Physical Work Conditions: 
•    Responsible for understanding and conforming to the Environmental Policy to ensure that significa