Product Development Engineer

Job Title – Product Development Engineer

Location – Franklin Lakes, NJ

Duration – 4+ months

Total Hours/week - 40.00
1st Shift

Client: Medical Device Company

Employment Type: Contract on W2 (Need US Citizens Or GC Holders Only)

No H1b’s

Description:

General Function:
Manages projects of low to moderate complexity by leading cross functional teams. Analyzes development situations and data with in-depth evaluation of multiple factors.

Influences solutions to business or technical problems. Communicates and implements the strategic and technical direction for the project team. Communicates project status to all stakeholders. Demonstrates a working knowledge of business & market growth drivers & trends. Complete understanding of a wide application of project management principles, theories & concepts.

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

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

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.

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