Senior Manager – Research & Development
Industry : Medical Device
The Senior R&D Manager will be an engineering professional, responsible for leading technical projects (e.g. new product development and sustaining engineering) through a matrix of cross functional groups. The primary responsibility for this role is to manage the technical and scientific development of new / existing projects. This role has responsibility for overseeing and approving design inputs and managing / reporting the technical status of development projects from R&D sites. The role is expected to establish the development strategy, oversee design reviews, and become the technical “go-to” person in R&D for all lateral flow platforms.
Additionally this role will ensure appropriate technical development timelines whilst achieving other design excellence metrics for new product development and Life Cycle Management activities. The Senior R&D Manager will advance platform development and drive existing product support through interactions with Commercial, Medical Affairs and other key business stakeholders.
The Senior R&D Manager will provide direct technical and organizational leadership to the R&D organization, ensuring a culture of innovation, as well as driving the design for manufacturability and reliability. This individual will also work with Quality and Manufacturing to ensure that processes are in place for all design activities.
- Provides technical leadership and centralized technical oversight for the R&D organization in the planning, development and execution of technical projects to achieve critical strategic business objectives. Manages multiple technical projects concurrently to ensure critical path technical challenges do not impact or minimize schedule impact.
- Competent in making difficult technical decisions regarding priorities among projects / programs while ensuring the buy in of teams and leaders.
- Provide technical leadership and clear direction to the R&D Engineering organization across multiple sites.
- Create and deploy development strategies while providing tactical leadership for medical device innovation and product support programs.
- Ensure a culture of innovation becomes second nature.
- Technical leadership of engineering R&D managers, principal engineers and the technical direction for all medical device development. Directly accountable/responsible for the technical deliverables of the R&D function.
- Responsible for management and clear communication of NPD (New Product Development) project portfolio for R&D engineering, including development of appropriate metrics for tracking and supporting continuous improvement efforts, e.g. design excellence.
- Lead Engineering Excellence in all we do across the R&D Engineering group
- Create and maintain development standards, training programs and operating procedures that ensure all development activities meet regulatory guidelines and comply with the Quality System.
- Ensure through technical direction that program milestones are achieved.
- Create and manage design inputs (user needs / VOC/ etc.) program working collaboratively with Commercial, Marketing, Medical Affairs, Regulatory, Customer Care and other stakeholders.
- Drive a robust CAPA process through the establishment of guidelines, operating principles, procedures and training curriculums. The guidelines should foster a design for six-sigma culture, driving design for manufacturing and data driven design for reliability.
- Develop and maintain relationships with third level institutions, engineering test labs, key suppliers and appropriate consulting work providers.
- Collaborate closely with functional areas such as Quality, Manufacturing and Regulatory to support external audits and certification activities. This includes preparation as well as response to the audit findings.
Education & Competencies:
- BS/MS / B Eng degree in any of the following disciplines Science / Biologics / Bio Med / Engineering.
- Strong technical background in device and assay development considered.
- 15+ years of assay development and biologics essential.
- Additional experience in medical device development is considered a plus.
- 10+ years leadership experience and functional management required.
- Excellent problem solving methodology, using industry accepted concepts and tools to solve complex technical problems in creative and effective ways as they apply to compliance issue.
Leadership Characteristics: Making Complex Decisions
- Complex problem solving and decision-making based upon the available data.
- Leverages personal experience.
- Uses multiple problem solving tools as required to drive to a solution.
- Open and collaborative style.
- Writes and presents effectively; adjusts to fit the audience and the message; strongly gets a message across.
Managing Diverse Relationships:
- Effective at building strong cross functional relationships with the key stakeholders.
- Communicates complex technical challenges / status up and down the organization appropriately and effectively.
- Ability to develop relationship and collaborate with external suppliers and Key Opinion Leaders within related industries.
Acting with Integrity:
- Is a person of high character; is consistent and acts in line with a clear and visible set of values and beliefs; is direct and transparent but at the same time can keep confidences.
Travel: Yes, 25% of the time.