Product Development Engineer

ARCH•Kenosha, WI

21d

About The Position

This role involves supporting and participating in the design, testing, modification, fabrication, and assembly of prototypes, while maintaining detailed documentation throughout the development process. The engineer will utilize CAD software for design work, determine design specifications, and perform necessary adjustments. Responsibilities include investigating existing technology, developing new methodologies, materials, processes, and products, and supporting product development plans regarding schedule, cost, and design inputs. The role also involves reviewing customer prints, providing cost estimates, conducting quality checks on documents and reports, creating Bills of Materials, and conferring with other engineering personnel to ensure designs are manufacturable. Additionally, the engineer will identify and implement improvements for efficiency and cost savings, evaluate engineering test results, compile and analyze data to establish performance standards, implement test programs, and ensure projects are completed on time and within budget. Collaboration with other departments and participation in the plant leadership team to promote safety, quality, and teamwork are key. A hands-on approach is expected in working with front-line employees to promote continuous improvement. Other duties as assigned.

Requirements

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.

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.
Support 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.