Sr Design Engineer - Civco Medical

The Senior Design Engineer will drive mechanical designs, development of new and innovative medical products within the High-Level Disinfection and Men’s Health Business Unit. This position will strive to meet the needs of CIVCO’s customers by working cross-functionally with regulatory, engineering, product management, and all other departments. This position reports to the System Engineering Manager.

Essential Duties and Responsibilities include the following.  (Other duties may be assigned.)

1. Mechanical Design Engineering:  Invents, designs, develops, models, and documents new medical products.  Drives mechanical designs through conceptualization, documentation, prototype, verification/validation, and design to production transfer.  Provides support to Operations, Supply Chain, and Quality for technical or production issues that are mechanical or electrical in nature
2. Project Management:  Responsible for planning and scheduling of product development projects.  Includes providing inter/intradepartmental communication and information relating to new products, improving processes, developing cost estimates for projects and products, and supporting manufacturing projects.  Communicates with OEM customers on product specifications and other technical matters.
3. Quality Assurance:  Understands and follows engineer-related and company processes. Works closely with regulatory and quality engineering for all product development, design, and verification/validation activities. Preferred experience with ISO 13485, FDA, and MHLW requirements or similar ISO 9001 certifications.
4. Delegation and Coaching:  Coordinate and delegate new product component design, process improvement, and manufacturing support activities to other engineers and interns. Does not directly manage other employees.
5. Personal Development:  Attends all relevant training. Keeps up to date with relevant developments in Medical Devices and related technologies. Participates in clinical evaluations.

Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

Other Skills and Abilities

• Skilled in design, documentation, materials management, design for manufacturing, process management, design software management, and root cause troubleshooting/problem-solving.
• Extensive experience with Computer-Aided Design (CAD) tools (PTC CREO preferred).
• Experience within a Part Centric Product Life Cycle and Change Management system for the CAD database (Windchill preferred).
• Demonstrates interpersonal, organizational, and time management skills.
• Highly competent in mechanical design.
• Skilled in Tolerance Loop Analysis or geometric tolerance stack-up techniques, and GD&T.
• Experience with manufacturing processes including injection molding, machining, and mechanical assembly.
• Experience with Microsoft Office (Word, Excel, PowerPoint, Teams, OneNote, Outlook)
• Experience with design and implementation, utilizing a wide range of mechanical fabrication techniques and processes, including Metal/Plastic Molding, Welding, Material Forming, Machining, and Casting for a variety of materials.
• Knowledge of materials, BioMed, or Life Science Engineering is a plus.

Education and/or Experience

Bachelor's degree (BS) in engineering from a four-year college or university and five years related experience and/or training; or equivalent combination of education and experience. Medical device design or regulated industry experience preferred.  Experience with fluidics, electronics, and motion control is ideal.

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

While performing the duties of this job, the employee is regularly required to sit; reach with hands and arms, talk, or hear.  The employee is frequently required to use their hands to finger, handle, or feel.  The employee is occasionally required to stand; walk; climb or balance and stoop, kneel, crouch, or crawl.  The employee must occasionally lift and/or move up to 50 pounds.  Specific vision abilities required by this job include close vision, color vision, depth perception, and the ability to adjust focus.

Work Environment

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

While performing the duties of this job, the employee is frequently exposed to moving mechanical parts.  The employee is occasionally exposed to toxic or caustic chemicals and risk of electrical shock.  The noise level in the work environment is usually moderate.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c) Engineering