Senior Laboratory Manager
4 weeks ago
Job Summary
The R&D Lab Manager will provide leadership for lab operations for product development/R&D teams. The team supports the full technology lifecycle for technical feasibility, product development, and sustaining. The role requires strong technical leadership, expertise in lab operation, strong cross-functional collaboration, and communication & operational excellence with a continuous improvement mindset.
Key Responsibilities
- Responsible for development & tracking procedures, establishment and maintenance of service contracts and warranties with vendors.
- Accountable for compliance to Lab and MEIC procedure including presenting required evidence during audit.
- Directs and coordinates the laboratory support staff for R&D Project Lab activities & support.
- Plans and execute preventative maintenance and calibration for lab requirements. Maintains an adequate inventory of materials, and laboratory equipment.
- Ensures effective operation of all laboratory equipment and serves as point of contact for instrument repairs.
- May organize and participate in vendor negotiations, product and software evaluations, tutorials, and facility modifications.
- Interfaces with Employee Health and Safety (EH&S) and acts as a liaison between departments and the scientific staff to complete lab modifications and ensure safety compliance.
- Provides technical input to purchasing and other functional areas.
- May trouble shoot and repair general instrumentation.
- Trains new scientific staff in the general use and function of designated instrumentation and creates and refines user protocols for general use.
- Be the single point of contact for stakeholder holder communication, maintain dashboards.
- Enable operational excellence & continuous improvement initiatives.
- May have budget accountability for a department, function.
- Manages subordinate supervisors and/or experienced professionals who exercise latitude and independence in assignments.
- Provides tactical and / or operational leadership and coaching.
- Receives assignments in task and objective oriented terms. Risk identification and mitigation.
- Decisions impact program schedules, customer satisfaction levels, or allocation of time, material resources, expenditures and funds.
- Innovation and Complexity: Proposes modifications to functional operating policies and day-to-day processes.
- Problems and issues faced are complex, difficult and undefined, and require detailed information gathering, analysis and investigation to understand the problem.
- Communication and Influence: Communicates with internal and external customers and vendors regarding ongoing operations.
- Uses information exchange, influence and active persuasion without direct exercise of command to gain cooperation of other parties.
People Management Functional Career Stream
Management and supervisory professionals with one or more employees who are focused on tactical, operational and some strategic activities within a specified area. The majority of time is spent overseeing their area of responsibility, managing performance, developing talent, engagement and inclusion, communicating business and operational developments, planning, prioritizing and / or directing the responsibilities of direct reports. Goal achievement is typically accomplished through performance of direct and / or indirect reports. A key responsibility of roles in this career stream is managing people, which includes: accountability for mentoring, developing and coaching staff on meeting/exceeding performance expectations and defined objectives, providing leadership to staff ensuring the prioritization of strategic and department level initiatives to include defining performance goals and targets, conducting performance reviews, and staff 1:1s to guide performance management and employee development efforts and manage toward departmental goals.
Requirements
To be considered for this role, please ensure the minimum requirements are evident in your applicant profile. Bachelors Degree in Biomedical, Chemical, Electrical, or other sciences related field and 10 + years of engineering lab / product development experience and 5+ years of leadership or managerial experience. OR Advanced Degree in Biomedical, Chemical, Electrical, or other sciences related field and 3+ years of engineering experience and 5+ years of leadership or managerial experience.
Nice to Have
Prior work experience in a regulated industry (medical device, pharma, aerospace, defense). Experience working in a clean room environment or equivalent. Advanced degree in engineering, preferably Biomedical or Chemical, Electrical, or other sciences related field. Strong coaching and people leadership skills. Experience in R&D feasibility studies and product development. Effective engineering/analytical/problem solving skills in a team environment. Experience with statistical analysis of data, Gage R&R, ANOVA & significance testing at a minimum, using tools such as Minitab, JMP, MATLAB, etc. High degree of initiative and self-motivation. Excellent written and verbal communication skills; ability to present information to cross-functional audiences and management. Communication to governing bodies e.g. FDA, GMED, OMA, DOD, in USA and PMDA in Japan, are a plus. Experienced in technical documentation – SOPs, test protocols, engineering reports and publications, IQ/OQ/PQ reports, engineering/lab notebooks, etc. Demonstrated ability to translate complex technical information into simplified communication.
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