Product Development Engineer II

at  Quality Tech ServicesLLC

ABOUT QTS

QTS offers critical end-of-line services for medical device OEMs including finished device assembly, packaging and sterilization management. QTS is part of the Cretex Medical family of companies. Learn more at www.qtspackaging.com and www.cretexmedical.com.

PRODUCT DEVELOPMENT ENGINEER II IDEAL CANDIDATE PROFILE

QTS is currently seeking an energetic, responsive and well-organized full time Product Development Engineer II that will be responsible for new product design and project planning as well as ongoing support throughout the product’s life cycle. You will work in a dynamic and collaborative environment, ensuring compliance with quality requirements, customer specifications, and industry standards while driving innovation and efficiency in meeting customer needs. Your role will involve technical leadership, problem-solving, and continuous improvement initiatives.

PRODUCT DEVELOPMENT ENGINEER II JOB SUMMARY

• Analyze and interpret customer requirements and specifications to propose new package designs and end-of-line services (inspection, cleaning, packaging, labeling, sterilization, routine testing).
• Create and update design documentation (i.e., bill of material (BOM), process flow, control plan, inspection plan, shipping configurations, etc.) for both new and existing product lines.
• Assess feasibility of new project opportunities.
• Work with Estimating and cross-functional technical teams to build complete, competitive, and profitable project proposals and production quotes.
• Plan and manage technical aspects of new product initiation (NPI) project plans and timelines in collaboration with Project Managers.
• Write project Master Validation Plan (MVP) summaries for new projects inclusive of sealing, packaging, cleaning, and sterilization, by obtaining customer requirements and collaborating with technical specialists.
• Plan, execute, and own package design validations (package performance testing and stability testing) including formal validation protocols, sample preparation and testing work instructions, product conditioning plans, formal validation reports, change assessments, and adoption assessments.
• Work with suppliers and supplier quality to create QTS receiving inspection plans and component qualification plans for packaging and medical device components.
• Review and assess Process Engineering-, Supply Chain-, and Quality-initiated changes to ensure continued compliance to customer requirements.
• Provide product line and customer guidance to quality, production, supply chain, process engineering, manufacturing engineering, and others.
• Participate in or lead customer calls (discovery calls, routine project updates, etc.)
• Work directly with customer to negotiate, finalize, and document project and product requirements.
• Establish and maintain working relationships with key customer technical experts.

Product Development Engineer Skills and Experience

• Bachelor’s degree in engineering (Biomedical, Mechanical, Packaging, or a related field).
• 5 years of experience as an engineer in medical device industry or similar role. Knowledge of commonly used concepts, practices, and procedures in medical device end-of-line manufacturing.
• Basic proficiency with CAD software (e.g., SolidWorks, AutoCAD) for design purposes and previous technical writing experience.
• Awareness of standard statistical techniques such as capability analysis, ANOVA, design of experiments (DOE), normality testing, etc.
• Ability to read, understand, and interpret regulations and technical standards as they pertain to medical device packaging, cleaning, and sterilization. Knowledge and training pertaining to GMP, traceability and risk analysis.
• Effective verbal and written communication skills.
• Ability to work well in team-oriented environments, including working on and/or leading cross-functional project teams.
• Willingness to learn new processes and adapt to changing project requirements. Ability to prioritize, multitask and work in a fast-paced team environment.
• Proficient in Outlook, Word, Excel, PowerPoint, Teams, etc.

Please refer the Job description for details