bb7 is looking for a Sr. Director of Engineering to work with one of our clients, a worldwide leader in biotechnology. This position is responsible for managing and leading the product development team and process for instruments, including architecting at the system level and the design of firmware, software, electrical, mechanical, liquid-handling and optical subsystems. In partnership with the R&D team, application scientists, project management, marketing, and operations, the Sr. Director will meet company and business unit objectives for new product development by effectively utilizing worldwide resources.
- Responsible for the overall planning, execution, and success of instrument product development projects including meeting product development target metrics.
- Facilitate instrument product roadmap & prioritization process by soliciting input from business unit leaders and technical staff members and presenting summary to the executive team for prioritization and approval.
- Create compelling product concepts and requirements with clearly articulated value propositions in partnership with product management, R&D team, and engineering team.
- Propose instrument design modifications that leverage the advantages of proprietary research consistent with improving customer value propositions.
- Produce instrument designs that meet specifications for performance, ease of use, reliability and cost.
- Responsible for maintaining adherence to a product development process that meets QSR and ISO design control standards as applicable.
- Partner with manufacturing and QA to lead execution of a robust design transfer process that achieves reliability of manufacture and product quality expectations.
- Oversee all sustaining engineering activities as required to fix product defects, deal with part obsolescence, improve manufacturability, and manage cost of goods.
- Accountable for the technical input required for creating and maintaining intellectual property and avoiding infringement of competitors’ intellectual property.
- Collaborate globally with business unit leaders, marketing, R&D team, application scientists, and project management in the development of project scope and project benefits as a prerequisite for new product development planning.
- Provide guidance for R&D and project management regarding corrective actions, risk analysis, and improvements to new product development process with a focus on continuous improvement.
- Oversee safety and EMC compliance.
- Support operations, safety, and other business functions requiring the engagement of R&D and new product development.
- Support special projects related to new product development activities. Partner to help manage efforts, including QSR and Design Control and guide effort on complex projects that require the development of significant new processes.
- Continually improve new product development process through evaluation of internal and external customer feedback.
- Travel associated with new product development business objectives.
- Participate in activities required to achieve and maintain ISO and QSR compliance.
- Bachelor’s degree in Engineering, Life Sciences or related field required; Master’s degree preferred
- 7+ years of management experience developing instruments for life sciences or biotech
- Deep knowledge of a gated life cycle development process for hardware, software, and reagents
- Minimum of 10 years project management experience in a technical area within a cross-functional team environment
- Experience managing multi-national corporations strongly preferred
- Strong planning and organizational skills.
- Demonstrated interpersonal interactions conducive to sustainable creativity, effectiveness, and intellectual stimulation across all project stakeholders
- Demonstrated capacity to build and maintain organizations through appropriate staffing, training, and development of employees
- Strong communication and interpersonal skills to manage and work with a wide variety of personalities and cultures
- Experience with ISO 9001, ISO 13485, QSR, or other similar quality systems with a proven track record of producing high quality products
- Demonstrated record of achievement in research and new product development
bb7 and its Clients are equal opportunity employers and do not discriminate in employment on the basis of race, color, religion, sex, national origin, political affiliation, sexual orientation, veteran status, marital status, disability, age, membership in an employee organization, or any other classification protected by federal, state, or local law. We participate in E-Verify.