Job Type

Full-time

Description

Job Summary

The NPD Engineer - Process is responsible for supporting the design, development, and transfer of medical devices from concept through production, with a focus on manufacturing processes, tooling, and design for manufacturability.

This role works closely with customers and cross-functional teams to define requirements, develop robust processes, and ensure products are scalable, repeatable, and meet quality standards. The engineer contributes to both product and process development, with an emphasis on process capability, efficiency, and continuous improvement.

Job Responsibilities

Product & Process Development

• Supports design, development, and validation activities throughout the product lifecycle in alignment with project scope and objectives.
• Applies design control processes to ensure products are manufacturable, cost-effective, and compliant with applicable standards.
• Translates customer requirements into engineering specifications and process requirements.
• Supports design for manufacturability (DFM) and design for assembly (DFA) activities early in development.

Manufacturing & Process Implementation

• Develops and implements manufacturing processes, tooling, and fixturing to support production.
• Creates and maintains manufacturing procedures, test methods, and inspection plans to ensure quality and reduce risk.
• Supports engineering change implementation, including documentation updates and training of production personnel.

Testing, Analysis & Continuous Improvement

• Designs and executes experiments (DOE), testing, and characterization to evaluate and improve process performance.
• Applies statistical tools and engineering analysis to improve process capability and product performance.
• Evaluates new technologies and implements improvements to enhance efficiency and quality.

Collaboration & Project Execution

• Collaborates with engineering, operations, quality, and customers to support successful product transfer to production.
• Provides guidance and support to technicians and operators in prototyping, testing, and process development activities.
• Contributes to project deliverables and timelines through effective communication and coordination.

Business & Support Activities

• Provides input into quotes to ensure accuracy and quick turnaround.
• Performs other duties as assigned in support of business and organizational objectives

Requirements

• Bachelor's Degree in Engineering with 2 years of medical device experience.
• Strong understanding of design controls, process development, and characterization of test methods for selection, verification, and validation of components, sub-systems, and assemblies.
• Proficiency in 3D modeling (SolidWorks preferred) and working knowledge of drafting specifications.
• Complex problem-solving skills, including the use of statistical techniques such as DOE, ANOVA, t-tests, normality, and process capability metrics in decision-making.
• Strong technical writing skills.
• Excellent internal and external communication, presentation, follow-through, and organizational skills.
• Proven ability to work effectively with coworkers at all levels of the organization.
• Proven ability to lead other engineers and/or techs in supporting aspects of process development.
• Six Sigma Green/Black Belt Certification (preferred)

Benefits: Medical/Dental/Vision Insurance, Short-Term Disability, Long-Term Disability, Life Insurance, Paid Vacation Days, Paid Holidays, 401k.

The salary estimates are estimates from this job board and not a guarantee from Biomerics' salary range.

Biomerics does not accept non-solicited resumes or candidate submittals from search/recruiting agencies that are not already on Biomerics' approved agency list. Unsolicited resumes or candidate information submitted to Biomerics by search/recruiting agencies not already on Biomerics approved agency list shall become the property of Biomerics, and if Biomerics subsequently hire the candidate, Biomerics shall not owe any fee to the submitting agency.