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.
