Product Development Engineer

Roles & Responsibilities

Responsibilities:
The role will require cross-functional leadership, influencing and negotiation skills, and project management proficiency in addition to the ability to directly lead associates in project execution. Specific responsibilities include:

• Lead a cross-functional team, including R&D, Quality, Regulatory, Medical, and Manufacturing resources in managing and executing projects in support of global medical products.
• Execute proper project planning, including identification of critical paths, risk identification and mitigation, and contingency planning, utilizing appropriate project management tools.
• Ensure effective and efficient regular formal and informal project communications
• Lead and support execution of technical and/or cross-functional project work
• Support the portfolio of current products in terms of quality and regulatory compliance, manufacturing, and supply continuity
• Ensure implementation and rigor of BD 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.
• Motivate the team to achieve individual and program objectives
• Ensure compliance with BD quality policies, procedures, and practices
• Ensure compliance with all local, state, federal, and BD safety regulations, policies, and procedures
• Organize regular project meetings , working with project leaders to determine optimal meeting agendas.
• Work with project leaders to collect information to clearly communicate current status to Leadership Level

Experience Required

Experience:
• At least 3-5 years relevant experience in product development and design with at least 1 year product development and design experience in medical devices.
• Demonstrated experience leading cross-functional teams to complete product development from design through clinical trials and regulatory approval following a structured, phase-gated, product development process
• Experience in a regulated industry required, medical device experience required.

Skills & Certifications

Special Skills:
• Demonstrated experience in a technical leadership role on a cross-functional team
• Demonstrated experience in late-stage product development of medical devices through clinical trials and regulatory approval
• Demonstrated experience developing and monitoring budgets
• Demonstrated experience managing, mitigating and reporting risk on moderately complex projects; ability to provide risk estimated impacts to schedule and budget
• Demonstrated experience with change control management and prevention of scope creep
• 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.
• Desired experience in high volume plastics consumable manufacture
• Ability to manage multiple, senior external partner relationships (Clinical strategic partner, contract manufacturer)
• Ability to foster, coach and build effective cohesive teams

Eligibilities & qualifications

Position Requirements (As Applicable):
Education:
• Bachelor’s Degree or Master’s Degree in a technical field required.

Licenses Or Certifications:
• Program Management Professional Certificate Preferred