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Job Title: R&D Manager
Job ID: FL646
Location: Miami, FL
Industry: Medical Devices
Job Type: Perm
Description: 

 

Position Summary

 

Perform a wide variety of duties.  Reports to CEO.This person will establish global goals for the department, as well as, participating and/or manage R&D and Manufacturing Engineering activities.

 

Key Accountabilities:

 

  • Gather customer and market inputs to improve current products. 

  • Work with physicians to develop new products that meet the customer needs.

  • Assist the effort in complying with the regulatory requirements and design dossier preparation for new product and design changes.

  • Assist in company-wide goals of meeting GMP, ISO 13485 compliance.

  • Assist in supervising R&D support staff and implement adequate training programs for the technical growth of the staff.

  • Ensure that design controls are adequate and are being followed. 

  • Support market analysis and new business opportunities.

  • Assemble teams of cross-functional resources to support and lead new product development efforts.

  • Support product release with field training/support.

  • Support international congresses.

  • Ensure product teams are meeting goals through clear written objectives, follow-up and timely one on one reviews.

  • Develop intellectual property portfolio for products in development and or new product ideas for new business opportunities.

  • Ensure proper intellectual property clearance/evaluation for new products/features being developed for market.

  • Introduce new product/business ideas for market analysis.

  • Works with Marketing, Sales and Business Development to evaluate new business opportunities.

  • Determine product priorities based on market potential and return on investment.

  • Identify external resources to support design activities.

  • Work with Regulatory/Quality group to determine Regulatory and Quality Plan requirements.

 

This position requires cooperating with different company departments, such as Quality Assurance, Regulatory, Operations, Logistics, Finance and the other team members of the department.

 

Minimum Skills and Capabilities:

 

  • Excellent communication and leadership skills

  • Empowers colleagues in the team

  • Long term focus and planning

  • Strategic mindset

  • Team working

  • Delivers results

  • Customer focus

  • Stakeholder Management (internal and external)

  • Relationship management

  • Flexibility and adaptability to a fast changing environment

 

Requirements: 

 

Minimum Knowledge & Experience required for the position:

 

  • A bachelor's degree in an Engineering related field and at least 7 years’ experience in the endovascular medical device industry, OR Any appropriate combination of education and experience.

  • Thorough understanding of the human endovascular anatomy and related

  • Company products, solutions and services in terms of impact on the customer’s value chain (Clinical, Economical, Organizational)

  • Thorough understanding of competitor dynamics

  • Excellent grasp of profitability concepts and P&L influencers

  • Project management experience in the medical device industry.

  • Understanding of quality system (e.g. 21CFR820, ISO13485 ) and Regulatory requirements.

 

Compensation: 

$130-$140 +++

Contact: Jim Gurn
PO Box 3213
Boynton Beach
FL, 33424
Tel: (561) 200-0419
jbgurn@mricoastalgroup.com
Date Posted: 1/15/2018

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