SUMMARY:

This position is primarily responsible for working in a functional project engineering group within the department, consisting of multiple engineering disciplines. Involved in the design, development, documentation and validation and of new customer products, and modification of existing products including defining requirements, timelines, and deliverables with a focus on prototypes, process development, design verification, clinical builds, training production, and preparation for process validation and manufacturing transfer of products.

Responsibilities:

• Lead PE representative on project. Provide input on resources needed and project planning.
• Attends and arranges project meetings to discuss current and future design and development initiatives.
• May serve as a primary contact with clients on projects of moderate complexity.
• Assist with preparation of proposals and quotations for clients; interface as needed to resolve questions in a timely manner.
• Assist in preparation and maintaining of project plans to satisfy milestones, deadlines, budgets, and medical device quality regulations with required actions. Track and communicate project status, plans, issues, timelines, action items, and budgets.
• Provide guidance and direction to coworkers on areas of technical expertise.
• Troubleshoot production processes as required.
• Evaluate and select appropriate test methods for product requirements.
• Responsible for the following project inputs:
  • Feasibility builds, documentation, and testing
  • Equipment selection
  • Process development and documentation
  • Device Verification samples and testing
  • Operator training
  • Process Failure Mode Effects Analysis
  • Clinical builds
  • Process Validation
• Involvement in the full design, development, and validation requirements of projects, including:
  • Product design and specification creation, including mechanical and electrical components, assemblies, and packaging.
  • Materials sourcing and device prototyping.
  • Design verification and validation activities, including data for regulatory submission.
  • Manufacturing transfer and support of existing product lines as applicable.
• Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

• Willingness to travel, if required.
• Must maintain high ethical standards
• Must demonstrate good organizational skills.
• Ability to train new engineering employees on project engineering activities and Cirtec policies and procedures.
• Must be able to read, write and speak fluent English.
• A Bachelors’ degree in an engineering discipline with 5 years of relevant experience; Associates degree in an engineering discipline w/10 years of relevant experience; or equivalent.
• Experience in an engineering/manufacturing environment with a mix of mechanical design, tool design and manufacturing process experience.
• Strong computer skills, including the MS Office suite and MS Project.

Must be able to fully interpret technical drawings, blueprints, specifications, illustrations, and written documents.

• Strong analytical skills, must be able to obtain and evaluate secondary research information.
• Ability to learn and apply new technology.
• Moderate knowledge of engineering principles, technical writing, material properties, good tooling practices, and statistics.

PHYSICAL DEMANDS:

While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls. The employee is occasionally required to stand, and/or walk. The employee must occasionally lift and/or move up to 10 pounds while moving files or small packages. The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

Protective Clothing Required: None

WORKING ENVIRONMENT:

Work is performed in an office environment. The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

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