Sr Engineer

Job#: 1368461

Job Description:

Sr. Engineer

Irvine, CA

Description:

Applies knowledge of R&D engineering principles and methods to ensure compliance with regulatory requirements and systems/procedures to optimize product development, internal and external device manufacturing, and device distribution. Please refer to the job description for additional details.

Key Responsibilities:

• Apply mechanical and biomedical engineering principles to the design and development of components for the delivery system.
• Develop and execute test methods and procedures to evaluate device performance.
• Assign support tasks; gives instruction to technicians on conducting tests; trains technicians and provides feedback; and may coordinate technician work.
• Maintain accurate documentation of concepts, designs, drawings, and procedures. Generate written protocols, reports, and technical justifications/summaries.
• Other incidental duties assigned by Leadership

Additional Skills:

• Proven expertise in usage of MS Office Suite
• Strong documentation, communication and interpersonal relationship skills including negotiating and relationship management skills
• Working knowledge and understanding of statistical techniques
• Previous experience working with test lab equipment required (if applicable)
• Substantial understanding and knowledge of principles, theories, and concepts relevant to Engineering
• Strong problem-solving, organizational, analytical and critical thinking skills
• Good leadership skills and ability to influence change
• Knowledge of Design Control
• Knowledge of applicable FDA regulations for medical device industry desirable
• Ability to interact professionally with all organizational levels
• Ability to manage competing priorities in a fast paced environment
• Must be able to work in a team environment, including inter-departmental teams and key contact representing the organization on contracts or projects
• Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations

Education/Experience:

• Bachelor's degree in engineering required.
• 5-7 years experience required.

Must haves:

• Prior expert experience with medical device design verification & validation
• Proficient knowledge of statistical analysis (Minitab is used)
• Worked with FMEA and risk documentation

EEO Employer

Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at [email protected] or 844-463-6178.