The Product Sustaining Engineer is responsible for driving process, manufacturing and sustaining engineering activities for commercially available orthopedic implants and instrumentation, ensuring the continued supply of marketed products and components while continuously improving production processes and quality. This person works closely with the CAD Manufacturing, Research and Development and Software Engineering divisions to develop and maintain production processes and manage resources for the efficient automation of patient specific implants and instrumentation. Ensure consistent high quality of Conformis implant products and procedures through high attention to detail and diligence.
Essential Duties and Responsibilities:
Understand our product lines in order to provide engineering support for all aspects of assigned product line to ensure design intent, quality, and cost.
Create and evaluate new and existing design procedures, ensuring relevance, efficiency and quality of methods.
Acknowledge and participate in research programs, quality assurance and quality improvement projects carried on in the company.
Work with the divisional leaders to improve the quality of designs by implementing design controls.
Works with divisional and corporate staff to resolve more complex software or data issues related to implant design and production.
Oversees process improvements, CAD process validations and implementation efforts for CAD production.
Develops process specifications and user requirements with respect to CAD production related software.
Responsible for planning, coordinating and managing CAD process development activities to ensure that process knowledge is transferred successfully from development to CAD production.
Resolve issues through our quality system with products that are currently being manufactured.
Manage and monitor training systems to ensure adherence to design procedures.
Maintain effective working relationships and communication with departmental and other corporate staff.
Conducts and coordinates appropriate tests and collection of data related to production methods to ensure accuracy and quality.
Performs tasks under the company FDA and ISO-conforming quality system.
Perform all other duties as directed or assigned.
Qualifications and Experience:
Minimum of 2-3 years of experience using 3D CAD modeling software.
Degree in CAD or engineering discipline.
Mechanical or Biomedical engineering experience preferred.
2-3 years of medical device CAD experience preferred.
Skills, Abilities, Competencies Required:
Must have interpersonal skills (verbal and written) sufficient to interact effectively with customers and coworkers.
Willingness to work flexible hours as needed.
Must have the ability to adapt to changing pace within the department, with frequent interruptions.
Must possess project management skills.
Must demonstrate flexibility and willingness to adapt to diverse roles as a member of the corporate team.
Strong knowledge and experience in the following areas is preferred:
Product Lifecycle Management systems and processes
Analysis and assessment of MES processes
Must be aware of hazards within the company; adhere to safety standards established by FDA and other regulatory agencies.
Able to work in changing environments (reduced lighting, increased noise, temperature variances, unpleasant odors, etc.).
Willingness to learn needed skills on the job in order to enhance performance.
Understands completely various production and quality processes.
Be proactive and anticipate tasks required to complete assignments
Be able to communicate thoughts and ideas fluently both verbally and in writing. Adept at communicating complex process and concepts to offsite suppliers.
Conformis is an Equal Opportunity Employer