Sr. Manager of Concept Development

Resonetics; Fridley (MN); On-site; USD 118,000 - 171,000; Full time

Job summary

Resonetics is seeking a Sr. Manager of Concept Development to lead the Concept Development Engineering team and oversee a broad portfolio of concept-stage medical device projects.

The role requires at least 5 years in medical device environments, strong leadership, and deep knowledge of ISO 13485 and Design Controls. You will liaise with cross-functional teams to drive rapid prototyping and development strategies.

Qualifications

• Bachelor's or Master's degree in engineering, physical sciences, bio-engineering, or related field preferred.
• Minimum 5 years' experience in medical device, life science, or pharmaceutical companies.
• Excellent interpersonal and communication skills.

Responsibilities

• Build, lead and manage the Concept Development Engineering team.
• Manage a large portfolio of concept stage programs to ensure staffing, execution and customer satisfaction.

Skills

Leadership

People management

Communication

Multi-tasking

Education

Bachelor's or Master's degree in engineering

Job description

Overview

Resonetics is a global leader in advanced engineering, prototyping, product development, and micro manufacturing, driving innovation in the medical device industry. With rapid expansion across all our locations, we continue to push the boundaries of technology while fostering a dynamic, employee-centered culture. Our commitment to excellence and continuous improvement makes Resonetics an exciting place for professionals passionate about shaping the future of micro-manufacturing and being part of something bigger.

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.

Join Resonetics and be part of a team that's redefining medical device manufacturing. If you're passionate about innovation and thrive in a fast-paced environment, we'd love to hear from you.

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

Required Qualifications

• 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 Demands

• 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

Compensation

• The typical base pay range for this role is between $118,000-171,000/year. Compensation may vary based on individual job-related knowledge, skills, expertise, and experience. This position is eligible for a discretionary annual incentive program driven by organization and individual performance.
• Our company policy is that we are unable to provide visa sponsorship. Candidates must already be legally authorized to work in the United States without the need for sponsorship now or in the future.