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.