Sr. Manager of Concept Development

Reposted 11 Days Ago
Be an Early Applicant
Fridley, MN, USA
In-Office
118K-171K Annually
Senior level
Healthtech • Professional Services • Design • Manufacturing
The Role
Lead and grow the Concept Development Engineering team to manage multiple concept-stage medical device programs. Oversee staffing, execution, customer relationships, ISO 13485 compliance, design controls, cross-functional coordination, technical resourcing, estimating for new business, capability gap mitigation, and team career development to support the product design and development roadmap.
Summary Generated by Built In

Description

Job Summary

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. 

Essential Functions:

  • 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

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.

  

Physical Requirements

  • Prolonged periods of sitting at a desk and working on a computer
  • Must be able to lift up to 25 pounds at times
  • Must have excellent hand-eye coordination
  • Must wear gown, gloves, ear protection and other personal protective equipment when applicable

 Summary of Benefits

  • Group health & welfare benefits: Options for Medical, Dental and Vision insurance, Health Savings Account (requires participation in eligible medical plan), and Flexible Spending Accounts.
  • Company-paid benefits: Employee Life Insurance & Accidental Death & Dismemberment (AD&D), Long Term Disability (LTD), Kavira (requires participation in medical plan).
  • Voluntary, employee-paid benefits: 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 
  • Benefits and incentive compensation may be subject to generally applicable eligibility, waiting period, contribution, and other requirements and conditions.

Compensation

  • The typical base pay range for this role is between $118,000-$171,000/year. Actual base compensation will be based on individual job-related knowledge, skills, expertise, and experience. 
  • This position is eligible for the Resolution Medical annual incentive program.
  • 401(k) Plan: Company-provided Safe Harbor Contribution of 3% of eligible earnings. 

Skills Required

  • Bachelor's or Master's degree in engineering, physical sciences, bio-engineering, or related field
  • Minimum 5 years' experience at medical device, life science, or pharmaceutical companies
  • Prior experience in personnel management
  • 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
  • Excellent interpersonal and communication skills
  • Ability to work under pressure with a strong sense of urgency
  • Ability to multitask and manage a high workload
  • Strong analytical and problem solving skills with ability to collect, summarize and report technical information
  • Ability to handle and be trusted with confidential and/or sensitive information
  • Ability to be flexible and handle multiple projects in an organized, timely manner
  • Ability to work overtime if needed
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The Company
HQ: Minneapolis, MN
Year Founded: 2012

What We Do

Resolution Medical, LLC is a medical device development and manufacturing company specializing in complex delivery systems, active implantable devices, and component manufacturing. They provide comprehensive support from concept development through commercial-scale manufacturing for Class I, II, & III medical devices.

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