Job Description Summary

Within Integrated Diagnostic Solutions, the PMO is looking for a highly talented and driven individual with a passion and proven track record for product development and engineering. The incumbent will provide leadership to a cross-functional team responsible for defining and developing a high volume, disposable medical device.

Job Description

The role will require cross-functional leadership, influencing and negotiation skills, and project/program management proficiency in addition to the ability to directly lead associates in project execution. More specifically, your responsibilities may include:

• Lead a cross-functional team, including R&D, Quality, Regulatory, Medical, and Manufacturing resources in managing and executing a new product development project.
• Lead and support execution of technical and/or cross-functional project work
• Ensure implementation and rigor of product development processes and design control procedures
• Demonstrate strong and clear accountability for operational and program success
• Demonstrate leadership, learning agility, and action orientation when facing uncertainty. Instill confidence through leadership and actions
• Motivate the team to achieve individual and program objectives
• Foster the development of team members to excel in their performance, both functionally and cross-functionally
• Contribute to a culture of innovation by proactively generating novel concepts to improve current product performance or enhance current products’ ability to address customer needs.
• Ensure compliance with BD quality policies, procedures, and practices
• Ensure compliance with all local, state, federal, and BD safety regulations, policies, and procedures

Requirements

• Minimum of 6 years experience as a product development engineer or project/program manager in the medical device or other regulated industry (experience with FDA class II or III medical devices preferred);
• Bachelor’s Degree in a technical field required. Master’s Degree in technical field and/or MBA preferred.
• Demonstrated Experience leading cross-function teams to complete product changes through a structured, phase-gated, product development process;
• Experience in a regulated industry required, medical device experience preferred.

Desired Experience

• Demonstrated experience in a technical leadership role on a cross-functional team;
• Demonstrated experience with all phases of the Design Control process;
• Demonstrated understanding of the requirements management process experience in developing design inputs, design verification strategy and implementation;
• Demonstrated understanding of medical device product development risk management methodologies;
• Demonstrated understanding of product development considerations for tightly controlled, high-volume manufacturing processes;
• Clear understanding of manufacturing process validation including FAI/FAT, process development and IQ/OQ/PQ
• Proficiency in Microsoft Project or equivalent project planning software;
• Strong analytical and problem-solving skills;
• Demonstrated ability to clearly and effectively communicate (verbal & written) concepts; and
• Good understanding of business / finance concepts (e.g., payback, rate of return, cashflow, income statement)

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Primary Work Location

USA NJ – Franklin Lakes

Additional Locations

Work Shift