R&D Project Manager

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New Hope, MN
$120,000 - $130,000
Job Type
Direct Hire
Mar 26, 2018
Job ID
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This Position is responsible for the coordination of department and division activities during the product development process and management of assigned departmental personnel.
  • 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.
  • 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