Sr. Mechanical Engineer 8/19/2016
Medical Devices & Diagnostics Company
JOB DESCRIPTIONEXCELLENT OPPORTUNITY WITH GLOBAL FORTUNE 300 MEDICAL DEVICE ORGANIZATION!
SR. MECHANICAL ENGINEER
LOCATED IN KALAMAZOO, MI
GREAT CAREER ADVANCEMENT OPPORTUNITIES
RELOCATION ASSISTANCE AVAILABLE
SUMMARY OF POSITION
Design Engineers are an integral and vital part of our client's research and development teams. With a focus on new product development, they interface with numerous functions of the business, including marketing, R&D, clinical, regulatory, and operations. Their primary focus is to design and deliver products that will delight our customers around the globe. More importantly though, they have the opportunity to apply their technical abilities to improve the practice of medicine with innovative and enabling designs. Whether working in ProEngineer, running complex analyses with Ansys, brainstorming new concepts, or working with our model and test groups to evaluate their latest prototype, Design Engineers are focused on ensuring that we deliver the products that support our corporate mission to make healthcare better.
For this position, we are looking for an experienced Mechanical Engineer having a solid track record of leading multiple class 2 and/or class 3 electro-mechanical medical devices all the way from concept to commercialization. The successful candidate will have the opportunity to work with some of the top technical professionals in the medical device industry, bringing cutting-edge technologies to market. Specifically, this role is with our surgical robotics group which is focused on generating revolutionary technologies that we believe will change the way medicine is practiced.
Successful incumbents are passionate coaches and cooperative partners with their colleagues in research, development, operations and other departments that are both internal and external to our client. Key responsibilities for this role include:
* Lead the technical execution of engineering research, design, and product development projects.
* Work with surgeons, nurses, and other medical professionals to develop solid user needs, product requirements, and design specifications.
* Exercise individual judgment and initiative in the application of engineering principles, techniques and methods.
* Enforce standard work practices and the sound application of engineering principles to all elements of the design process.
* Leverage computer aided design tools to implement and assess design approaches.
* Select components and equipment based on analysis of specifications, reliability and regulatory requirements.
* Lead evaluations of vendor capabilities to support development.
* Coordinate with other divisions, vendors and senior managers as needed to ensure specific cost, time and/or regulatory standards are met.
* Lead and participate in design reviews for both intra and inter-divisional projects.
* Lead bottom-up risk management efforts.
* Create design control and otherrequired documentation in accordance with established standard operating procedures.
* Exercise administrative authority for engineering drawings, BOMs and engineering change orders.
* Review and approve engineering change orders.
* Develop clear & concise reports that include data analysis, interpretations, and recommendations.
* Report project status to senior management.
* Coordinate the technical activities of other engineers.
* Train and mentor others on engineering principles, techniques, methods and other functionally related topics
EDUCATION & QUALIFICATIONS:
* Bachelor of Science degree from an accredited 4-yearengineering program in Mechanical Engineering or related discipline. Candidates having M.S. or Ph.D. degrees are highly preferred.
* 6 or more years of electro-mechanical medical device design engineeringexperience with increasing levels of responsibility, preferably spanning multiple new product development cycles. Precision machine design and/or robotic experiencepreferred.
* Expert level understanding of mechanicalengineering design principles and practices. Conversant understanding of electrical / software / controls engineering design principles and practices.
* 3 or more years of experience leading cross-disciplinary design efforts, including giving direction to junior engineers.
* A genuine passion for engineering design evidenced through both personal and professional accomplishments.
* Expert level skill in parametric solid modelling (PTC CREO preferred) and GD&T. Surface modelling and PTC Mechanism experiencepreferred.
* Expert level analytical skills, including tolerance stackup analysis (Sigmetrics CETOL preferred) and application of applicable statistical tools and techniques (Minitab preferred).
* Recent experience leveraging Finite Element Analysis. Conversant with dynamic, vibration, fatigue, stress and thermal techniques (ANSYS, LMS Virtual Lab, or Mechanica preferred).
* Hands-on electro-mechanical aptitude, including selection, setup and implementation of sophisticated manual / automated test instrumentation.
* Significant experienceapplying Design for Manufacturability concepts.
* Significant experience leading risk analysis processes and applying risk analysis tools (DFMEA, Fault Tree Analysis, etc.).
* Excellent English oral and written communications skills.
* Professional Engineer license preferred.
* Class 2 / 3 medical device experiencepreferred.
* German language skills preferred