Senior Design Engineer, Product Development

RESPONSIBILITIES:

• Formulates and implements research and development programs, policies, and procedures required to support profitable growth.
• Interfaces with appropriate internal and external resources to ensure intellectual property are appropriately protected.
• Provides technical assistance for diagnosing design and manufacturing quality problems.
• Guides development and documentation of test plan protocols, standard operating procedures, specifications, and test procedures.
• Participates in review boards for intellectual property, CAPA, complaints, business unit planning, and others as necessary.
• Reviews and provides functional approval for project and quality system documentation.
• Tracks and forecasts divisional and product and technology projects.
• Support all Divisional initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
• Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
• Experience working in a broader enterprise/cross-division business unit model is preferred.
• Work in a highly matrixed and geographically diverse business environment.
• Work within a team and as an individual contributor in a fast-paced, changing environment.
• Leverage and/or engage others to accomplish projects.
• Strong verbal and written communication with the ability to effectively communicate at multiple levels in the organization.
• Multitasks, prioritizes, and meets deadlines in a timely manner.
• Strong organizational and follow-up skills, as well as attention to detail.
• Ability to travel approximately 10%, including internationally.

REQUIRED QUALIFICATIONS:

• Bachelor’s Degree in a technical field, preferably mechanical, chemical, biomedical, industrial, or quality engineering; materials science, biochemistry, chemistry, physics, or management.
• Minimum of 5 years relevant experience.
• Solidworks or similar CAD programs.
• Medical Device experience.

PREFERRED QUALIFICATIONS:

• A Master’s Degree in a technical or business field is preferred.
• Understands FDA Regulations.