Senior Mfg. Quality Engineer

Paragon Medical, a business of AMETEK, is a trusted partner in medical device manufacturing, offering end-to-end solutions from concept to final production. With expertise across various applications, we deliver high-precision components and complete products tailored to exceed customer expectations. Job Summary Responsible for meeting internal customer manufacturing quality requirements for new product launches through robust process design, documentation and controls. The position will participate in customer-focused teams facilitating all activities associated with multiple product launches between customers, supply chain, and Paragon. Responsible for performing new and existing product and process validations, including new product First Article Inspection (FAI or PPAP), while supporting Paragon Medical Process and Design Excellence (Six Sigma) objectives. This position will also be responsible for the development of ongoing compliance with internal systems and procedures to meet certified requirements, as well as developing and implementing inspection/validation techniques necessary to verify products meet customer requirements at the earliest point in the production process. Additionally, this position will continuously facilitate proactive solutions to safeguard customer and business needs, as well as lead problem identification and resolution by anticipating outcomes and preparing the team to deal with potential eventualities. Duties and Responsibilities Leads and creates manufacturing process development including work instructions, tooling, fixture design, value stream mapping, process & product characteristics, CTQ’s and DMR. Primary technical input for DFM with Client. Primary point of contact for Client regarding Quality requirements Creates DMR development for NPI launch, including process flow development/router, bill of materials, labor standards, pFMEA development, customer/internal prints, packaging, & oversees development of Engineering Masters. IQ/OQ/PQ protocol development and final reports. Supports NPI process with NPI PM. Ensure use of simulation tools for software where applicable & techniques such as dFMEA, pFMEA and risk management. Supports quoting activities, process outline and costing. Leads pFMEA development & team discussions along with managing risk mitigation activities & testing. Lead engineering test protocol development & reporting for process characterization & process testing. Responsible for profitability of process. Control plan development including inspection methodology, prevention controls, detection controls, reaction plans, inspection frequency rationale, & SPC. Supports lock down completion process. Communicates with customers in order to determine specifications of components and negotiate product design and process deliverables. Leads project requirements checklists through justification and/or rationalization of activities associated with product launches. Coordinate and lead launches of new processes including establishing goals, training team members and evaluating results. Identifies excessive tooling costs, develop methods for cost reductions, and implements identified cost reductions. Leads engineering test protocol development and reporting for process characterization and process testing. Apply statistical methods and perform process analysis for cost reduction, quality improvement and improved efficiency. Designs and develops manufacturing processes in support of engineering for new products, and other in-house applications; i.e. gages, tooling, setup and work instructions, and fixtures. Designs and specifies required inspection equipment and holding apparatus to accommodate repeatable measurements. Represents company in meetings with customer to fully develop their requirements or as required in the manufacture of contracted products. Client point of contact. Ensures that the customer requirements have been identified and are adequately communicated, including but not limited to, “soft requirements” such as documentation, process limitations and quality requirements. Regularly completes gage R&R studies, training others in statistical techniques and process control/validations Leads, supports or participates in the Material Review Board (MRB) for internal non-conformances and customer returns. Designs inspection/validation steps to be taken by operations at the point of manufacture and integrate these steps into the manufacturing instructions. Responsible to create, implement and improve quality systems and procedures for meeting ISO, FDA and customer quality system requirements. May be required to train or lead others in similar roles Other duties, as assigned. Education Minimum 4 Year / Bachelors Degree, Mechanical engineering or related field Preferred 4 Year / Bachelors Degree, Mechanical engineering or related field 2 Year / Masters Degree, Mechanical engineering or related field Experience 7+ years, Manufacturing quality engineering role. 7+ years, Related manufacturing machining or processes. KSA's Ability to effectively lead with little supervision. Excellent interpersonal skills and ability to develop, motivate, and influence people. Working knowledge of computer systems. Ability to assess situations and solve problems in a timely manner. Excellent verbal and written communication skills. Ability to determine and meet deadlines. Ability to work independently as well as part of a team. Analytical thinking skills. Strong problem solving, decision making, and process improvement skills. Proficient blueprint reading, GD&T, working knowledge of short run process control methods, statistical analysis, DOE, ISO standards, and FDA quality system regulations. Knowledge of Design for Manufacturability (DFM) principles, biocompatibility requirements for materials, ISO 13485 and US QSR 21 CFR, Part 820 Medical Devices, and basic understanding of the human anatomy preferred. Knowledge of various metal and polymer materials as well as testing specifications preferred. Physical Demands Demand, Frequency Sitting, Frequent Standing, Frequent Walking, Frequent Use hand/fingers to grasp/pinch/grip, Frequent Climbing (stairs/ladders) or balancing, Frequent Stoop, kneel, crouch, or crawl, Frequent Operating machinery and/or power tools, Occasional Operating motor vehicles or heavy equipment, Occasional Activity-Weight Demand-Frequency Lift, 0-10lbs, Occasional Carry, 0-10lbs, Occasional Push, 0-10lbs, Occasional Pull, 0-10lbs, Occasional Work Environment Work performed in an office environment. The noise level in the work environment is usually low. Disclaimer Paragon Medical, provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws. Job Type: Full-time Pay: $90,000.00 - $105,000.00 per year Benefits: 401(k) 401(k) matching Dental insurance Employee assistance program Employee discount Flexible spending account Health insurance Health savings account Life insurance Paid time off Parental leave Retirement plan Tuition reimbursement Vision insurance Schedule: Monday to Friday Education: Bachelor's (Required) Ability to Relocate: Pierceton, IN 46562: Relocate before starting work (Required) Work Location: In person