Position Title: Principal R&D Engineer
Department: R&D and Operations
Reporting Relationship: VP, R&D and Operations
FLSA Status: Exempt
The Principal R&D Engineer is responsible for leading Engineering design and development activities within ASI including contract manufacturing suppliers and distribution centers. They will ensuring successful completion of projects and coordination of activities to meet company goals; ensuring compliance to applicable standards and regulations; ensuring world-class product performance; operating cost-effectively; and identifying areas & driving deliver of projects to achieve continuous improvement. Individual shall collaborate with ASI stakeholders and suppliers to plan for and execute project activity to meet product and production performance requirements.
• Provide Technical leadership and project management while working with other business partners to assure that process development, scale up, manufacturing issues and project timelines are consistently met per corporate objectives.
• Directly manage R&D project activity at contract manufacturing organizations, including contract negotiations, training, validation, and continuous monitoring of manufacturing performance.
• Technical leadership of the development of new products and/or the improvement of existing product, supporting the successful transition to manufacturing using design and manufacturability concepts, as applicable.
• Responsible for working with Quality including supplier monitoring and audits, risk management and internal controls while ensuring compliance with ISO 13485 and other relevant standards and regulations pertaining to medical device and pharmaceutical products.
• Contribute to the successful execution of departmental and company goals.
• Regularly update and recommend to ASI stakeholders the status of objectives, projects, and goals, particularly how they relate to cross-functional business objectives.
• Support business partners by providing technical leadership for company’s long-term manufacturing and distribution channels.
• Development and execution of commercial manufacturing timelines consistent with project and regulatory needs;
• Financial modeling for COGS and scaling up production capacity.
• Technology transfer to partner or contract manufacturing organizations, as applicable
• Promote and support a continuous improvement culture and drives cost saving initiatives.
• Create and manage annual budget for R&D project activities.
• Provide strong integrity, vision, knowledge, and overall aptitude to the organization.
• This position may or may not have direct supervisory responsibilities, depending on the needs of the company and as determined by the CEO and reflected on the Organizational Chart.
• Bachelor’s degree in Engineering or related specialty.
Experience / Knowledge / Skill Requirements
• A minimum of 10 years’ experience with at least 5 years in a Technical leadership role in a biotechnology, pharmaceutical or medical device industry experience required.
• Experienced in working within ISO 13485/FDA regulated quality systems.
• A proven track record in process scale up for investigational product supply for clinical trials and early commercial manufacturing of biopharmaceutical, pharmaceutical products or medical device products is required. Combination product experience a plus.
• Ability to achieve results in a virtual organization. Experience working with cross-functional teams, project facilitation and demonstrated ability to complete projects on time.
• Well versed in the Product Development Process, including Risk Management and Design Controls
• This role is primarily technical in nature; thus they seek someone who is passionate about Engineering concepts and principles – someone who gets a thrill from how and why things work
• A seasoned professional in engineering development with extensive engineering knowledge and skills in some or all of the following: Concept development and selection, technology evaluation, driving innovative solutions to complex problems, process design and development, materials (polymers and metals), design for six sigma principles, CAD (Solidworks preferred), statistical techniques, process validation and control.
• Understanding and application of risk management methodology
• Excellent analytical and decision-making skills
• Possess a flexible, pro-active approach to problem solving, be an adept negotiator and apply risk-based decisions
• Ability to develop and maintain strong collaborative relationships with all functional departments of the organization
• Strong organizational, communication, interpersonal, managerial and leadership skills
• Ability to effectively and efficiently manage consultants, suppliers, vendors and budgets.
• Ability to work in a fast paced, high growth environment. Ability to handle multiple tasks with high quality and timeliness standards.
Physical Demands and Conditions Requirements
• This position may be remote home-office based or company office based, depending on where the incumbent resides. It requires approximately 10% travel, which may include trips to visit vendors and suppliers, attend applicable scientific congresses or R&D/Manufacturing trade shows, and internal meetings.
• General office equipment.
• Engineering specific equipment.
Interested candidates should submit their resume and cover letter to: email@example.com