Job Description

The Senior New Product Integration Engineer is responsible for leading cross-functional efforts to ensure successful execution of new product launches and major product changes. Engaging early in the design process, this role ensures that Regenesis’s infrastructure—including manufacturing, quality, information technology, supply chain, and regulatory systems—is fully prepared to support scalable production and market introduction. This position plays a critical leadership role in creating comprehensive launch plans, identifying risks, and aligning cross-functional teams to deliver smooth, on-time, and high-quality product introductions.

Essential Duties and Responsibilities

The essential functions include, but are not limited to the following:

• Early Design Engagement
• Collaborate with R&D, marketing, and regulatory teams early in the design process to gather appropriate requirements and ensure they are translated and included in the design process.
• Represent Manufacturing Engineering in product development core teams.
• Launch Readiness & Planning
• Lead the development of cross-functional NPI launch plans, including detailed readiness checklists and execution timelines.
• Work closely with individual departments (Manufacturing, Quality, Regulatory, IT, Supply Chain, and Service) to define readiness plans for their respective areas, and hold appropriate team members accountable as launch approaches.
• Ensure all stakeholders are aligned and resourced to meet program milestones.
• Infrastructure & Process Development
• Assess and prepare Regenesis’s internal and external capabilities (vendors, equipment, processes, documentation) to support production scale-up.
• Oversee planning development and qualification of tooling, fixtures, test systems, and assembly processes.
• Lead equipment validations (IQ/OQ/PQ) and process validations as required.
• Change Management & Compliance
• Drive execution of large product changes through structured change control processes.
• Ensure all activities comply with FDA QSR, ISO 13485, and other applicable regulatory requirements.
• Cross-Functional Leadership
• Act as the central point of contact for all NPI-related activities across functions.
• Facilitate regular readiness reviews and risk assessments; resolve roadblocks and drive issue closure.
• Communicate program status (including budget) to leadership, escalating critical issues as needed.
• Post-Launch Support & Continuous Improvement
• Monitor early production and field feedback to identify issues and continuous improvement opportunities.

Minimum Qualifications (Knowledge, Skills, and Abilities)

• Bachelor’s degree in Engineering (Electrical, Mechanical, Biomedical, Manufacturing, or related field). Master’s degree a plus.
• 7+ years of experience in medical device manufacturing or product integration, including 3+ years in a lead or senior role.
• Demonstrated success managing new product introductions or large-scale changes in a regulated (FDA/ISO 13485) environment.
• Strong understanding of DFM/DFA principles, validation, and quality systems.
• Proven ability to lead cross-functional teams and deliver complex projects on time and within scope.
• Excellent communication, organizational, and problem-solving skills.

Preferred Qualifications:

• Experience with connected devices (medical or other).
• Experience with Class II/III medical devices and electro-mechanical systems.
• Lean or Six Sigma certification.
• Working knowledge of risk management tools (FMEA, Fault Tree, etc.).
• Experience managing external manufacturing partners and suppliers.

Information for Applicants

Applicants must have existing work authorization that does not require employer sponsorship. Unfortunately, requests for visa sponsorship, including but not limited to H-1B, TN, or similar programs, cannot be accommodated for this role.

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