Our client a well-known Milwaukee based Medical Imaging Products company seeks a Senior Product Development Manager. This person must have good people management skills even if it is on a project management basis. To them titles are not important as much as the individuals outgoing personality, team building, critical thinker who can interface with customers. They want this person out of a highly regulated industry preferable medical device, CT or MRI Hardware products.
Position Summary: The Senior Product Development Manager is responsible for defining the overall strategy, roadmap and development of new generation MR Ready medical devices to meet the needs of the company’s business and end user. This will be accomplished by soliciting customer feature needs through consistent interaction with customers and distilling user needs into key market requirements for new products, taking into account user workflows and needs, and understanding market needs and direction. The Senior Product Development Manager will translate this into product definition including: clinical and technical capabilities, service features, benefit to meet customer needs and product requirements.
Drives MR Ready medical device technology innovation prior to and during new production development (NPD) programs. This position is responsible for providing management and engineering expertise in the development and sustaining activities of new MR Ready medical devices.
This position will drive the voice of the customer throughout the organization as it pertains to MR Ready medical devices.
The Senior Product Development Manager is accountable for the development, planning and growth of technically qualified and skilled engineering teams.
- Collaborates with customers, researchers and clinical leaders to develop a product roadmap, MR Ready medical device offerings, clinical and technical requirements, intended use, indications for use, product differentiators, value propositions, and target markets / sales opportunities.
- Oversees the NPD process for MR Ready medical devices, serves as the “voice of the customer” and “voice of the company business” during NPD commercialization.
- Ensures the commercialization of new MR Ready medical devices meets quality, schedule, regulatory (i.e. IEC60601-1, ISO 14971, 21 CFR 820, ISO 13485, etc.) claims, cost targets; and ensures effective transfer into production.
- Supports the development of IP related to MR Ready medical devices including drafting of new disclosures, review of exiting patents and identification of relevant issued patents.
- Contributes directly to designs of MR Ready medical devices throughout the NPD lifecycle including new product development, installed-based, lateralization offerings, product changes and end-of-product/service life.
- Reviews and approves quality system (i.e. NCMRs, CAPAs and document change requests) and design related (i.e. engineering change orders, requirements, specifications, plans, reviews, test procedures, and test reports) documents in compliance with the company’s quality system requirements.
- Collaborates cross-functionally across engineering disciplines (i.e. mechanical, electrical, RF, test and technicians), program management, service, manufacturing, quality, regulatory, clinical applications, customers and suppliers.
- Manages engineering activities, performance and accountability. Mentors and improves capabilities and skills using goal setting and review processes, performance appraisals, developing individual development plans, and coaching/mentoring.
- Provides leadership, technical direction and support to engineering team to promptly identify, define and resolve engineering, design and development issues to meet multiple project needs and objectives.
- Business Acumen/Knowledge – Aligns work with strategic goals. Knows how business works. Demonstrates knowledge of current business practices and future trends. Knows the competition.
- Creativity/Innovation – Generates original thinking and creative solutions. Possesses ability to think “outside the box”, Comes up with new ideas and approaches not readily apparent or previously tried that enhance the organization’s systems or products, generates suggestions for improving work.
- Critical Thinking – Disciplined thinking that is clear, rational, open-minded and informed by evidence. Examines assumptions, reflective thinking by applying, analyzing and synthesizing information.
- Facilitation/Presentation Skills – Uses a variety of techniques/tools to conduct group discussions and to assist in group problem solving. Effectively communicates and presents in small or large groups. Prepares well, analyzes audience, and seeks innovative approaches to presenting ideas and materials.
- Management/Managing Others – Appropriately adapts style and approach to situation/person to achieve desired results. Improves processes and services, includes staff in planning and decision making. Provides regular performance feedback, takes responsibility, Works to improve management skills, Supports learning and growth in direct reports.
- Strategic Thinking – Focuses on the big picture to identify trends and create opportunities. Uses organizational processes and procedures to achieve outcomes, displays orientation to profitability, Understands business implications of decisions.
- Teamwork/ Team Building – Recognizes and builds on strengths of others. Looks for ways to build positive relationships on the work team, Demonstrates trust and respect for others. Balances team and individual responsibilities. Able to build morale and group commitments, supports everyone’s efforts to succeed. Puts success of team above own interests, Give and welcomes feedback.
Essential Skills and Experience:
- Bachelor of Science degree in Engineering/technical discipline; an advanced degree (Masters, PhD) preferred.
- A minimum of 10 years’ in an engineering or product development role.
- A minimum of 5 years’ clinical experience, preferably within MR imaging.
- Experience with MRI systems, diagnostics imagining, medical device design controls and MR related physics and equipment.
- Product management skills, creating technical marketing requirements, producing product marketing collateral and experience in development of product roadmaps.
- Must exhibit a high level of initiative, as well as demonstrate the ability to work independently or direct others to develop technical solutions to complex problems that require ingenuity and creativity.
- Possess a systematic approach to problem solving and issue resolution combined with a good understanding of the relevant technologies and their practical applications.
- Strong understanding of quality management systems, medical device regulations and standards, including 21CFR820, MDD 93/421EEC, MHLW, M0169, ISO13485, IEC60601-1.
- Exceptional communication skills; able to provide direction, organize, prioritize, schedule, negotiate and communicate relevant project information.
- Excellent client interface and relationship building experience.
- Experience with market analysis, value propositions, price point determination and revenue projects.
- Product development/ management skills, and experience in development of new MR Ready medical devices and project execution.