New Product Introduction Engineer

Intuvie; Natick (MA); On-site; USD 110,000 - 170,000; Full time

Job summary

Intuvie is seeking a Senior Engineer for New Product Introduction to bridge engineering and manufacturing, ensuring DFM and smooth tech transfer to external partners. You will coordinate with R&D, Quality, Regulatory, and Production Facilities to optimize new product launches in a CGMP environment.

The ideal candidate has 5+ years in medical device development, strong CAD skills, and a proven ability to lead cross-functional transfer projects from development to full-scale production.

Qualifications

• Bachelor of Science in Manufacturing, Mechanical or Electrical Engineering or equivalent experience.
• Five or more years in related work experience in a medical device environment.
• Understanding of elements of design that impact product cost and quality; ability to influence cost and quality early in design.
• Experience with the full development life cycle of durable medical equipment and disposables.
• Proficient in CAD software such as SolidWorks; Six-Sigma Green Belt is a plus.

Responsibilities

• Provide guidance on manufacturability, robustness, DFM, and process development during new product development and post-market support.
• Lead design transfer activities to external manufacturing partners; include cost analysis, process and equipment development, supplier capability, and documentation control.
• Lead the Change Control process for product or process improvement projects.
• Create design transfer plans, schedules, and deliverables; document project activities.
• Work closely with suppliers, purchasing and development to ensure design specifications are defined and met.
• Analyze and improve the effectiveness of current contract manufacturing processes.
• Analyze and improve the efficiency and quality of manufactured parts and sub-assemblies.
• Develop efficient process flow, manufacturing fixtures, and work instructions with contract manufacturers.
• Develop DFM best-practices and guidelines.
• Assist in evaluating, resolving, and auditing quality issues.
• Provide Lean Manufacturing guidance at contract manufacturers to reduce waste.
• Initiate continuous improvement projects across the company.
• Oversee vendor selection, installation, and qualification of tooling and equipment.

Skills

Analytical skills

Organizational skills

Communication skills

Hands-on skills

Problem-solving

Self-motivation

Education

Bachelor of Science in Manufacturing, Mechanical or Electrical Engineering

Tools

SolidWorks

Six-Sigma Green Belt

Job description

Senior Engineer, New Product Introduction Eng

Job Description

GENERAL SUMMARY

The New Product Introduction (NPI) Engineer at Intuvie facilitates the transition of new products and product changes from the engineering team to the manufacturing team. Successful candidates possess a blend of technical and hands-on experience in medical device development and manufacturing. Experience with the detailed requirements of CGMP, familiarity with general product quality management, and manufacturing engineering and process development are important for this role. The NPI Engineer will be a key member of the engineering team, ensuring DFM during development while being responsible for technology transfer activities with internal teams and external manufacturing partners to transition products from development to full scale production. The job responsibilities are broad and require flexibility, attention to detail, and good organization skills.

ESSENTIAL JOB FUNCTIONS

• Work with Engineering, Quality, and External Manufacturing teams to provide guidance on manufacturability, robustness, DFM, and process/supplier development during new product development and post market/sustaining support.
• Owndesign transfer activities to external manufacturing partnersfor both new productsand product changes. Activities could include, but not limited to: Cost analysis, processand equipment development,suppliercapabilitydevelopment, control of Manufacturing and Quality documentation.
• Leadthe Change Control process forproduct or process improvement projects.
• Create design transfer plans,schedules, and deliverables. Document project activities.
• Work closely with suppliers,purchasingand development to ensure designspecifications are adequately defined and met.
• Analyze and improve the effectiveness of current contract manufacturing processes.
• Analyze and improve the efficiency and quality of manufactured parts and sub-assemblies.
• Develop efficient process flow, manufacturing fixtures, and manufacturing work instructions in collaboration with contract manufacturers.
• DevelopDFMbest-practicesand guidelines.
• Assistin evaluating, resolving, and auditing quality issues.
• Provide guidance for Lean Manufacturing at Contract Manufacturer to reduce waste
• Initiate continuous improvement projects throughout the company.
• Oversee and Support Contract Manufacturer for the selection, installation, qualification (IQ/PQ/OQ) of tooling and/or capital equipment utilized in product manufacture.
• Provide progress reports to management as required.

OTHER DUTIES AND RESPONSIBILITIES

• May contribute directly to new product engineering or product design changes depending on resource availability.
• Review product designs for manufacture ability content.
• Develop Quality Management System procedures to refine the New Product Introduction/Design Transfer process.

PREPARATION, KNOWLEDGE, SKILLS & ABILITIE

• SBachelor of Science inManufacturing, Mechanical or ElectricalEngineering or equivalentexperience
• .Five or more yearsinrelated work experience in a medical device environmen
• tUnderstanding ofelements of design that impact product cost and quality. Ability to influence the cost and quality of new products early in the design process
• .Experience with the full development life cycle ofdurablemedical equipment and disposables.
• General understanding of all manufacturing operations within the company and at our contract manufacturers and their supplier
• sExcellent analytical, organizational, written, verbal communication, and hands-on skills
• .Works cooperatively with R&D, Quality and Regulatory, Production Facilities, Supply Chain, and Marketing on complex projects to ensure project succes
• sProficient in Computer Aided Design software such as SolidWork
• sExperience with statistical methods. Six-Sigma Green Belt isa plus
• .Able to prioritize and take initiative with minimal guidanc
• eAble to helpfacilitateactions and work with others across multiple departments and organizations
• Strong problem-solving skill
• sSelf-motivate
• dAbility to work effectivelyto meet deadline
• sSolid organizational skills-able to handle multiple tasks simultaneousl
• yWorking knowledge of Microsoft applications including MS Projec