Product Development Engineer

ARCH; Kenosha (WI); On-site; USD 90,000 - 110,000; Full time

Job summary

ARCH, located in Kenosha, Wisconsin, is looking for a dedicated individual to lead the medical device design and production management. The ideal candidate will have a strong background in engineering and experience in the medical device industry, emphasizing timely project completion and adherence to quality standards. This role involves collaborating with cross-functional teams to achieve operational excellence.

The position offers a competitive salary range from $90,000 to $110,000, depending on experience.

Qualifications

• Bachelor's degree in Engineering or equivalent experience.
• 5-10 years of production management experience preferred.
• Proven track record in medical device design and development.

Responsibilities

• Support design, test, modification, fabrication, and assembly of prototypes.
• Provide cost estimates and time standards for manufacturing operations.
• Ensure projects are completed on time and within financial budgets.
• Promote safety, quality, and teamwork within the plant leadership team.

Skills

Medical device design and development

Leadership

Project management

Geometric Dimensioning and Tolerancing per ASME Y14.5M

ISO 13485 Quality Management System

FDA 21CFR 820 Regulations

Education

Bachelor's degree in Engineering or Manufacturing Engineering

5-10 years of experience in production management

Job description

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.

Salary Range: $90k-$110K depending on experience.