Sr. Manager of Concept Development

RESOLUTION MEDICAL LLCMinneapolis, MN
$118,000 - $171,000Onsite

About The Position

The function of the Concept Development Organization is to provide Engineering Services in support of prototype to concept stage realization of Medical Device Product Innovations for start-ups to Fortune 100 sized clients. The Sr. Manager of Concept Development is responsible for ensuring the organization operates in a manner aligned with Resolution’s core values and maintains compliance to all regulations and company procedures.

Requirements

  • Bachelor’s or Master’s degree in engineering, physical sciences, bio-engineering, or related field preferred
  • Prior experience in personnel management desired
  • Minimum 5 years’ experience at medical device, life science, or pharmaceutical companies
  • Strong understanding of ISO 13485 Compliant Product Development Requirements and associated Design Controls
  • Experience with implant, catheter design, anatomy/device interactions, or device related treatments preferred
  • Excellent interpersonal skills and communication skills
  • Must be able to work under pressure with a strong sense of urgency
  • Ability to multitask and manage a high work load
  • Strong Analytical / problem solving skills with a demonstrated ability to collect, summarize and report technical information
  • Ability to handle and be trusted with confidential and/or sensitive information
  • Able to work in a fast-paced, constantly changing environment
  • Ability to be flexible and to handle multiple projects in an organized, timely manner
  • Able to problem-solve, work under pressure, and to effectively manage stress
  • Ability to work overtime if needed.

Responsibilities

  • Build, lead and manage the Concept Development Engineering team
  • Manage a large portfolio of small concept stage programs to ensure staffing, execution and overall customer satisfaction is achieved
  • Ensure that all technical and support personnel are properly qualified, trained and supervised
  • Interface between Concept Engineering, Design & Development, Product Realization, Process Development, Program Management and Executive teams
  • Provide oversight of the management of customer relationships for projects in the Concept Stage (Gate 1) of the Stage Gate Process
  • Continue to develop business relationships with customers in support of their business models, supplying Engineering Services and intellectual network access as appropriate
  • Support the Resolution Medical Product Design and Development Technology Roadmap in support of Strategic Investment Planning
  • Develop engineering services estimates in support of new business, with both existing and potential clients
  • Define and allocate technical capability in support of projects
  • Identify and mitigate gaps in technical capability and resource capacity
  • Support human resources, quality, operations and R&D departments as necessary to ensure compliance with requirements.
  • Directly manage team in support of career development and company goals

Benefits

  • Options for Medical, Dental and Vision insurance
  • Health Savings Account (requires participation in eligible medical plan)
  • Flexible Spending Accounts
  • Employee Life Insurance & Accidental Death & Dismemberment (AD&D)
  • Long Term Disability (LTD)
  • Kavira (requires participation in medical plan)
  • Employee Supplemental Life & AD&D
  • Spouse and Dependent Life & AD&D
  • Short Term Disability (STD)
  • Accident, Critical Illness, and Hospital Indemnity
  • Employee Assistance Program
  • Flexible Time Off Program
  • Paid Parental Leave
  • Paid Holidays
  • 401(k) Plan: Company-provided Safe Harbor Contribution of 3% of eligible earnings.
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