Sr. Product Development Engineer

ARCH; Kenosha (WI); On-site; USD 108,000 - 132,000; Full time

Job summary

ARCH in Kenosha, Wisconsin is seeking a senior engineer to lead design and development of medical devices. The role involves prototyping, testing, and refining processes while maintaining thorough documentation.

You will work with CAD tools, review customer prints for accuracy, and drive cost estimates, schedules and quality standards to meet print specifications. A strong leadership presence and PM skills are essential for success in this manufacturing environment.

Qualifications

• Bachelor's degree in Engineering or Manufacturing Engineering or equivalent.
• Five to ten years of experience in production management and/or training.
• Proven track record in medical device design and development.
• Knowledge of emerging trends and ability to influence best practices in Medical Device development.
• 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

• Design, test, modify, fabricate and assemble prototypes and document development process.
• Use CAD tools for design work and CAD documentation.
• Set design specifications and calibrations; adjust as needed.
• Evaluate existing tech; implement new materials and processes.
• Review customer prints for accuracy against specs and quality standards.

Skills

Medical device design

Leadership

Project management

Quality systems

Continuous improvement

Design for manufacturability

Emerging trends awareness

Education

Bachelor's degree in Engineering / Manufacturing Engineering

Tools

CAD software

Drafting tools

Job description

• 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.
• 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.

Equal Opportunity Employer
This employer is required to notify all applicants of their rights pursuant to federal employment laws.For further information, please review the Know Your Rights notice from the Department of Labor.