Senior Manager Engineering Operations, NPI

Resonetics•Blaine, MN

3d•$118,000 - $171,000

About The Position

The Sr. Manager Engineering, Ops NPI (New Product Introduction) at Resonetics is a key leader who plans, manages, and coordinates high value, multi-site programs involving vertically integrated technologies, processes, and businesses. Reporting to the Director, Engineering, Ops NPI, this role will work cross functionally to optimize and deploy an efficient New Product Introduction process to accelerate production implementation of new products and technologies. This includes opportunities that originate within Resonetics Lightspeed Lab group as well as other external “transfer-in opportunities” as they arise. The role will enable Operations readiness for growth, including network space readiness, proactive capacity planning to accelerate growth across the Resonetics Operations site network. This Leader must work closely with the broader Resonetics Lightspeed Lab and commercial team members to build, monitor and prioritize a healthy pipeline, as well as the global Operations/Engineering teams to ensure effective pull and integration into manufacturing. Typical programs involve multiple Resonetics design and manufacturing locations, complex supply chain networks, and working with site Directors of Operations, Lightspeed development teams, commercial and business development leaders, procurement, and other operations function site-level resources to plan and execute key initiatives. Resonetics is a global leader in advanced engineering, prototyping, product development, and micro manufacturing, driving innovation in the medical device industry. With rapid expansion across all our locations, we continue to push the boundaries of technology while fostering a dynamic, employee-centered culture. Our commitment to excellence and continuous improvement makes Resonetics an exciting place for professionals passionate about shaping the future of micro-manufacturing and being part of something bigger.

Requirements

Bachelor’s degree required in engineering or related technical discipline.
Minimum of 10 years of experience leading technical programs in the medical device industry. Strong process validation experience, project/program management and leading cross functional teams in operations and process development environments.
Experience managing cross-functional teams in a matrixed environment, with a strong focus on design transfer, process validation, manufacturing scale & launch, and line transfer projects across multiple sites.
Proficiency within the Medical Device Product and Process Development space, including (understanding print requirements, process characterization, FMEA, IQ, OQ, PQ, TMV, and deep statistical analysis) and setting process validation strategies.
Proficiency in project management tools (e.g. MS Project, PowerPoint) and strong analytical skills for problem-solving.
Exceptional verbal and written communication skills, with expertise in setting and managing stakeholder expectations.
Strong negotiation and influencing skills, particularly in environments where resources may not be directly controlled.
Solid team leadership, team building and facilitation skills. Ability to facilitate a collaborative working environment for customers and team members.
Excellent conflict resolution and arbitration skills.
Strong executive presentation skills, with the ability to regularly engage and present to all levels of the organization, including executive leadership.
Strong background with FDA CFR Part 820 and ISO13485.

Nice To Haves

Experience with Contract Manufacturing a plus.
PMP certification preferred. Advanced certification or degree in project management beneficial.

Responsibilities

Leads and manages internal resources through dotted line relationships to meet program goals and milestones. Works cross functionally with internal management to ensure appropriate resources have been assigned.
Work closely with internal global cross-functional teams and subject matter experts as well as external technical partners to plan and develop project scope, deliverables, required resources, detailed work breakdown structure, project budget, costing analysis, risk mitigation plans and project timing.
Regularly publish progress status reports to leadership and stakeholders highlighting achievements, milestone deliveries, associated metrics and provide visibility to the pipeline.
Understand, track and articulate issues / risks / action items; work with responsible owners to address the items on a timely basis; update the appropriate stakeholders as needed.
Proactively communicate escalations around challenges, resourcing, and support required to stakeholders and leadership to ensure timely resolution before they impede successful delivery of the program.
Keep projects on track and ensure timely completion within the defined scope, accountable for successfully meeting or exceeding commitments on product performance, schedule, product cost, cycle time, budget and quality.
Generate high-level plans, communications, schedules, and meeting minutes with actions/decisions to assist with task prioritization and workload adjustments.
Identifies potential project risks and develops/implements strategies to minimize impact and control deviations from estimated costs and project deadlines.
Coordinates the procurement of materials, supplies, services and controls necessary for timely and cost-effective completion of project within budget.
Delegate and manage tasks among team members as appropriate to drive execution of project deliverables, minimize risk, and leverage the organization.
Ensure current Resonetics policies and practices are followed, and accurate documentation requirements are followed.
Identify resources required for project activities, develop project budgets, resource allocations and timelines.
Interact with senior personnel on complex matters requiring coordination between organizations. Proactively partner with Business Development teams to develop strategies to win key opportunities for Resonetics.
Selects process improvement techniques to solve technical problems and makes sound equipment and process recommendations.
Specific deep experience in process and equipment validation, test method equipment, test method development and validation, product design transfer, process optimization, cost improvement, facility layout and line transfers between facilities is required.