R&D Project Manager

Twitter Facebook
Location
New Hope, MN
Salary
$120,000 - $130,000
Job Type
Direct Hire
Date
Mar 26, 2018
Job ID
2583628
Get Social with us:  Like us on Facebook,  Follow us on LinkedIn… Follow us on Twitter… 
Be the FIRST to know about NEW CAREER Opportunities!

This Position is responsible for the coordination of department and division activities during the product development process and management of assigned departmental personnel.
 
Responsibilities:
  • Coordinates and/or directs all aspects of product development activity related to a product line.
  • Coordinates product development activities of R&D/Product Development teams, including integrations of RA, QA/QE, Operations, Clinical, Marketing, Sales and Packaging Engineering for a product line.
  • Participates as team leader or as an active member of the team to meet company objectives and ensure department responsibilities are completed.
  • Assesses priorities and makes assignments to direct reports to ensure project and company priorities are met.
  • Performs supervisory responsibilities for direct reports to ensure project and company priorities are met.
  • Performs supervisory responsibilities for direct reports, including but not limited to, performance reviews, recommending salaries and promotions, training, interviewing and hiring decisions and disciplinary actions.
  • Identifies development needs and potentials of employees, and provides or recommends project assignments and training to increase expertise to meet current or future division’s needs.
  • Provides technical support and feedback for direct reports.
  • Coordinates with team members, internal and external suppliers and outside professionals to ensure project output meet users’ needs as well as applicable regulatory requirements.
  • Actively participates in training and providing input to training of employees on division procedures and policies.
  • Creates, tracks and meets project schedules, plans and budgets.
  • Reviews and analyzes costs in order to identify and implement cost improvements.
  • Provides input, feedback and maintenance for department and division procedures and policies.
  • Complies with company procedures and policies, government regulations.
Qualifications:
  • B.S. degree in Biomedical Engineering, Chemical Engineering or other related engineering discipline, or equivalent experience.
  • Minimum 7 years of industrial experience in R&D or process development, preferably in medical device or other regulated FDA/QSR and ISO Environment.
  • A minimum of 2 years’ experience in a supervisory capacity.
  • Demonstrated knowledge of development, manufacturing and quality systems requirements for medical devices required.
Preferred Qualifications:
  • Experience with balloon catheters, stents and stent delivery systems preferred.
  • Experience in process validation (IQ, OQ and PQ), including writing protocols and reports to support verification and validation activities for product commercialization.
  • Experience in drug coating, active pharmaceutical ingredient handling, and working in a controlled environment.
  • Knowledge of cGMP and GLP is a plus.
  • US FDA QSR and ISO 13485 requirements for design controls.
  • Strong Skills in communicating with all levels of technical and operating management.
  • Demonstrated positive communication and human relation skills.
  • Strong ability to analyze and use technical data and resources.
 
Identifier: $MEDD, $NEER