Sr. 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.

- Conducts a quality check of all documents and reports, verifying accuracy of data, information, and calculations.

- Creates accurate manufacturing Bills of Materials from parts or assemblies to drive manufacturing, operations, quality, purchasing and logistics for a product.

- 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.

- Other duties as assigned.

Qualifications

- Bachelor's degree (Engineering, Manufacturing Engineering are strongly preferred) or equivalent.

- or 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.

Starting Salary Range: $120,000+ depending on experience.