NPD Engineer II

Job Posting Template SMC About Us:

SMC Ltd. is a globally recognized premium supplier to the medical market with locations throughout the world. People committed to speed, technology, and exceptional performance are the cornerstone of our organization. Comprised of dedicated people and decades of manufacturing experience, we have continued to experience strong growth and currently have outstanding career opportunities for equally dedicated people.

Job Summary:

The NPD (new product development) Engineer II performs multiple related duties in conjunction with other employees and departments contributing to the overall team effort, efficient process, and safe working environment. This position includes many essential components necessary for successful and efficient manufacturing, and as such, shares full responsibility for the final product delivered to the customer.

Essential Job Duties and Responsibilities:

Leads the transfer of new medical device products and manufacturing processes from development into high‑volume production. Partners cross‑functionally with R&D, Manufacturing Engineering, Quality, Supply Chain, and customers throughout the NPD lifecycle. Drives Design for Manufacturability (DFM) and Design for Assembly (DFA) for injection‑molded components and assembled devices. Supports tooling, mold design, fixturing, work‑cell layout, and automation development for scalable manufacturing. Develops, implements, and validates manufacturing processes for molded components and assemblies. Defines and executes validation strategies, including IQ, OQ, PQ, PPQ, and MSA, in compliance with regulatory requirements. Authors and maintains manufacturing documentation, including work instructions and Device Master Records (DMR). Ensures compliance with ISO standards, FDA regulations, and internal quality systems. Manages Release‑to‑Manufacturing activities to ensure production readiness, timeline adherence, and risk mitigation. Identifies process, equipment, and automation improvements to enhance quality, efficiency, and cost performance. Applies Lean Manufacturing and Six Sigma principles to support robust and repeatable product launches. Provides technical troubleshooting support during NPD builds and ongoing production. Essential Qualifications Bachelor s degree in mechanical engineering, manufacturing engineering, industrial engineering, or related engineering degree. 2+ years of experience in contract manufacturing; will consider recent college graduates if they have related internship experience. Strong understanding of mold design principles, mold flow analysis, and plastic part design. Strong project management and communication skills. This is a client facing role.

Desirable Qualifications:

Background in injection molding industry. Knowledge of lean manufacturing, Six Sigma, or continuous improvement tools. Experience in regulated industries (medical, medical device, pharma). What SMC has to offer? Clean, Climate-Controlled Environment Stable schedule Paid holiday and PTO Health, dental, and vision insurance 401(k) retirement savings Life and disability insurance Promotional opportunities Training and career growth programs Amazing co-workers Tuition reimbursement Employee Assistance Program We are committed to fair and equitable hiring with salaries based on relevant factors, such as work experience, education, and certifications. Toward the principle of equal pay for equal work, we post and hire within defined salary ranges. We ask all applicants to review salary ranges for each posted job opportunity, as we will not hire outside the predetermined range. At SMC Ltd. we recognize that people come with a wealth of experience and talent beyond just the technical requirements of a job. If your experience is close to what you see listed here, please still consider applying. We know that our differences often can bring about innovation, excellence and meaningful work-therefore, people from all backgrounds are encouraged to apply to our positions. Please let us know if you require reasonable accommodation during the interview process. SMC Ltd. is an equal opportunity employer. M/F/D/V; this organization uses E-Verify. Applicants may be subject to pre-employment screening which may include drug screening, reference checks, employment verifications, background screening and/or skills assessments. #LI- SH1 #IND