Engineer

Pay range: 30-40/hr
*depending on experience

This role will be required to:

Plan and author technical documentation, including test plans/protocols/reports and a variety of engineering assessments.

Perform hands on testing of autoinjector devices, including the safe operation of test equipment and devices containing sharps (syringes).

Analyze and report data, along with any recommendations, to a variety of stakeholders.

Provide technical input for mechanical problems to programs as needed.

Plan and execute tolerance and robustness analysis of complex mechanical designs.

Use project planning to monitor and track project deliverables to ensure accurate completion.

Collaborate with cross-functional teams to ensure adequate sustainment and improvement of products throughout their lifecycle.

As part of the team working on device platforms, ensure alignment of documentation to support variants and combination products.

Basic Qualifications

B.S. in Engineering or Scientific Discipline

Effective Communicator (Oral/Written)

Technical Writing (Protocols, Reports, Technical Assessments, Presentations)

Preferred/Demonstrated Competencies

Broad set of knowledge and expertise in contributing to complex, multi-disciplinary and cross-functional product development efforts

Experience in drug/device combination product design, and development

Background in development, commercialization, and lifecycle management of medical devices

Physical test method development, qualification, and validation

Experience executing lab tests, including safe and proper operation of lab equipment (Instron tensile tester, Keyence inspection equipment, manual and automated autoinjector testing, CT scanner etc.)

Experience conceptualizing, designing, and building test fixtures

Technical understanding of drawings including tolerance stacks and robustness analysis

Knowledge of Quality Management System, Quality Management Policy and applicable laws and regulations as they apply to this job type/position

Familiarity with the following standards: US Good Manufacturing Practices (21CFR820), Quality Management (ISO 13485), Risk Management (ISO 14971), EU Medical Device requirements (Council Directive 93/42/EEC), Needle Based Injection Systems (EN ISO 11608-1), and Medical Electrical Equipment (EN 60601)

Knowledge of dFMEA/pFMEA

Capable of working on multiple projects in a deadline driven environment

Strong oral and written communication skills, decision making, presentation, and organization skills

Ability to collaborate with other disclines within the technical team such as, systems engineering, design engineering, human factors, MSAT, packaging engineering and other functions e.g., drug product, drug substance and product quality.

Demonstrate ability to navigate ambiguity and provide a structured problem-solving approach

Track record of building or participating as a member of successful teams

Working knowledge of MS Office tools, Solidworks, Minitab or JMP and Smartsheet