NPI Staff Engineer

Resonetics is a global leader in advanced engineering, prototyping, product development, and micro manufacturing, driving innovation in the medical device industry.

The Senior NPI Engineer at Resonetics is a key leader responsible for managing New Product Introduction (NPI) projects involving vertically integrated technologies, processes, and businesses. Reporting to the Manager of Manufacturing Engineering, this role drives the production implementation of new products and technologies originating from Resonetics’ Light Speed Lab group, as well as other transfer-in opportunities. The Senior NPI Engineer also leads facility expansion and transfer projects across the broader organization.

Responsibilities

• Lead NPI projects from product design through full-scale implementation on production lines.
• Regularly publish progress reports to leadership and stakeholders, highlighting achievements, milestone completions, and key metrics.
• Identify, track, and communicate issues, risks, and action items; collaborate with responsible owners to resolve them in a timely manner and update stakeholders as needed.
• Proactively escalate challenges, resourcing needs, and support requirements to stakeholders and leadership to ensure timely resolution before they impact project delivery.
• Keep projects on track to ensure completion within scope, meeting or exceeding targets for product performance, cost, cycle time, project budget, and quality.
• Execute process validations (IQ/OQ/PQ) in compliance with regulatory requirements in the pharmaceutical/medical device field.
• Develop high-level plans, schedules, and communications to assist with task prioritization and workload adjustments.
• Identify potential project risks and implement strategies to minimize impact, controlling deviations from cost and schedule targets.
• Coordinate procurement of materials, supplies, and services to ensure timely and cost-effective project completion.
• Delegate and manage tasks among team members to ensure delivery of project objectives and minimize risks.
• Ensure adherence to Resonetics’ policies, procedures, and documentation standards.
• Apply process improvement techniques to solve technical challenges and make sound equipment and process recommendations.

Required Qualifications

• B.Sc. in Mechanical, Biomedical, Industrial, Chemical Engineering, or a related field.
• Minimum 8 years of experience leading NPI projects in the pharmaceutical or medical device industry, with proven experience in design transfer and transitioning products to full-scale manufacturing.
• Hands-on experience executing process and equipment validations (IQ/OQ/PQ).
• Strong project management experience leading cross-functional teams in an operational environment.
• Familiarity with quality and regulatory standards such as ISO 13485, GMP, and FDA QSR (advantage).
• Experience managing cross-functional teams in a matrix environment, with a focus on design transfer, manufacturing launches, and line transfer projects across multiple sites.
• Proficiency in project management tools (e.g., MS Project, Wrike, Monday.com) and strong analytical/problem-solving skills (e.g., Minitab).
• Exceptional verbal and written communication skills, with expertise in managing stakeholder expectations.
• High proficiency in English – spoken, written, and reading.