Product Development Engineer

Primary Responsibilities

• Support and participate in the design, test, modification, fabrication and assembly of prototypes, and maintain detailed documentation throughout the development process.
• Utilize drafting tools or computer-aided design (CAD) software for design work.
• Determine design specifications and perform necessary adjustments and calibrations.
• Investigate and evaluate existing technology, and develop and implement new methodologies, materials, processes and products.
• Supports product development plans (schedule, product cost, meeting design inputs).
• Reviews and checks customer prints for accuracy of product specifications, geometry dimensions and quality standards including verifying and discussing with customer as needed.
• Provides cost estimates and time standards for the manufacturing operations ensuring processes are up-to-date and in line with engineering and production requirements to meet customers’ print specifications.
• Creates accurate manufacturing Bills of Materials from parts or assemblies to drive manufacturing, operations, quality, purchasing and logistics for a product.
• Conducts a quality check of all documents and reports, verifying accuracy of data, information, and calculations.
• Confers with other engineering personnel and prepares design modifications as required to ensure designs can be produced by existing manufacturing or processes or methods.
• Identifies, recommends, and implements improvements and/or modifications in sequence of operations, equipment utilization to increase efficiency and cost savings.
• Evaluates engineering test results for possible application to developments of instrumentation or other uses.
• Compiles and analyzes operational, test, and research data to establish performance standards for newly designed product.
• Implements test programs and analyzes test data and reports to determine if design meets functional and performance specification.
• Ensures projects are completed on time.
• Ensures financial budgets are followed and met.
• Works closely with other organizational key leaders/departments to achieve cohesive workflow and desired business results (ex: Quality, Inventory, Engineering, MNTC, etc.).
• Serves as key member of the plant leadership team in promoting safety, quality and teamwork.
• Utilizes a hands-on approach in working with the front-line employees to promote and deploy sustainable continuous improvement activities.

Qualifications

• Bachelor's degree (Engineering, Manufacturing Engineering are strongly preferred) or equivalent.
• Five to ten years of experience in production management and/or training.
• Or equivalent combination of education and experience.
• Proven track record in medical device design and development.
• Knowledge of emerging trends and the ability to influence best practices within the Medical Device development discipline.
• Knowledge of Geometric Dimensioning and Tolerancing per ASME Y14.5M.
• Knowledge of ISO 13485 Quality Management System & FDA 21CFR 820 Regulations.
• Strong leadership and project management skills.