MINIMUM QUALIFICATION REQUIREMENTS
- Bachelor’s of Science degree or Master of Science degree in Engineering preferred.
- Bachelor’s degree or equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered.
- Minimum 8 years experience.
- Two years of GMP manufacturing experience required.
- Requires demonstrated skills in Test Method Validation, Design Verification, Statistical Analysis and Risk Assessment activities
- Demonstrated interactive skills in, cross functional participation and influence, mentoring and acceptance of guidance, technical leadership, project management, coordination with cross functional team member, team behavior, and support for subordinates, junior engineers, technicians, and management.
- Represents the organization as the prime technical contact on projects. Interacts with senior level external personnel on significant technical matters often requiring coordination between organizations.
- Follows and develops technical specification requirements and provides significant input on technical procedures on various processes that impact multiple disciplines.
- Knowledge and ability to implement FDA or regulatory requirements as necessary.
- Driver for acquiring resources and building consensus across products.
- Solicits and accepts the ideas of others, as well as actively contributes to an environment conducive to open communication.
- Regularly and effectively presents complex technical information/analysis, and responds to questions from technical staff members and management.
- Comprehensive knowledge of U.S., European and other international regulations, standards and guidance applicable to medical device development (e.g. ISO 13485, FDA GMP, 21 CFR 820, ISO 14971, EU MDR)
- Experience with Software as a Medical Device and knowledge of 62304 and Agile development methodologies preferred
- Six-Sigma and/or Lean Training preferred
- Demonstrated ability to communicate effectively both verbally and in writing.
- Knowledge and use of relevant PC software applications and skills to use them effectively.
An equivalent competency level acquired through a variation of these qualifications may be considered.
Aleron companies (Acara Solutions, Aleron Shared Resources, Broadleaf Results, Lume Strategies, TalentRise, Viaduct, and Aleron?s strategic partner, SDI) are Equal Employment Opportunity and Affirmative Action Employers. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender identity, sexual orientation, national origin, genetic information, sex, age, disability, veteran status, or any other legally protected basis. The Aleron companies welcome and encourage applications from diverse candidates, including people with disabilities. Accommodations are available upon request for applicants taking part in all aspects of the selection process.
Applicants for this position must be legally authorized to work in the United States. This position does not meet the employment requirements for individuals with F-1 OPT STEM work authorization status.