Works with and across the various disciplines of the engineering team, operations, quality, regulatory, and business development for project realization. One of the primary functions of the position is to be the technical leader, control DHF documentation and be the project manager to drive development projects. This will be achieved by establishing proper design specifications, project plans, and other DHF documentation to meet customer requirements.
· Responsible for product development projects to support growth of the business.
· Accountable for achieving quality objectives, creating/meeting development schedules and project budgets, as well as communicating program status and escalating issues when appropriate to facilitate transparency.
· Leading cross-functional program activities for timely completion of projects within budget.
· Managing and optimizing project plans, product/project risk, project budgets, and resources/task assignments.
· Working closely with cross functional team members to effectively facilitate decision making to deliver effective and timely new product development products.
· Ensuring compliance to design control procedures, Design History File (DHF) and other QMS requirements
· Managing customer objectives, regulatory requirements, schedules, and program risks.
· Participation as group facilitator and/or creator of documentation of requirements, inputs, outputs, specifications and test protocols/reports in support of Verification and Validation activities.
· Contribute to documentation needed for the Design History File and Technical File.
· Ensure project team activities and decisions are clearly communicated, documented and archived.
· Maintain working knowledge of the system design and performance against the requirements.
· Clearly communicate project objectives, schedules, and system performance with management.
· Performs other duties as assigned.
SKILLS AND QUALIFICATIONS:
· A Bachelor’s Degree of Science in Biomedical/Mechanical/Electrical Engineering or related field
· A minimum of 7 years of related industry experience
· 3+ years project management in a cross-functional environment.
· Design and development in regulated industries required, preferably medical device background and working knowledge of IEC 60601-x, ISO 13485.
· Demonstrated strong knowledge and experience of Project Management to create project schedules with task relationships.
· Proven ability to look ahead and plan while anticipating and prepping activities for execution in an effective and efficient method.
· Ability to create a schedule while collaborating cross functionally to ensure accuracy.
· Experience in the medical device industry and exposure to medical device development over multiple projects/life cycles
· Experience with working in ISO 13485 and 21 CFR Part 820 compliant environments.
· Proven experience with Design Control Process and management of sub-teams or significant project efforts.
· Skilled in leading multi-disciplinary teams including Engineering, Regulatory, Quality, Purchasing, Planning, and Production, in an FDA regulated environment.
· Proven ability to communicate clearly and concisely to provide information, direction, and or guidance.
· Proven Self-starter with an ability to multi-task.
· Proficient in MS Office Suite
· Assume responsibility and ownership with minimal direction and guidance.
· Exercise initiative and judgement with data driven decision making.
· Provide support to team members, customers, and others in the company as required.
· Ensure all regulations, policies, procedures, or processes are followed as specified by the company.
· Utilize standards and best practices where appropriate.
· Maintain a safe working environment.
· Hands on approach to problem solving.
· Expected from time to time to put in extra time and effort to complete critical tasks to meet deadlines or objectives for the company.
INTERPERSONAL AND COMMUNICATIONS SKILLS:
· Team Environment: Must be able to work in a fast paced team environment and collaborate in a positive and professional manner. This may include taking on tasks and responsibilities overlapping with other team members.
· Conflict: Must be able to negotiate and resolve issues with team members and management in a positive and professional manner.
· Communication: Must be a strong communicator able to convey clear and concise information to team members, management, or customers. Good listening skills are required.
· Ownership: Must be able to take ownership of problems, issues, or challenges with minimal guidance to troubleshoot and work through them.
Must possess the ability to read, write, speak, and comprehend the English language. Must be able to read, analyze, and interpret documents such as safety rules, operating and maintenance procedures.
Job Type: Full-time
Pay: $107,633.00 - $130,384.00 per year
- 401(k) matching
- Dental insurance
- Employee assistance program
- Flexible schedule
- Flexible spending account
- Health insurance
- Health savings account
- Life insurance
- Paid time off
- Referral program
- Tuition reimbursement
- Vision insurance
Ability to commute/relocate:
- Irvine, CA 92614: Reliably commute or planning to relocate before starting work (Required)
- Are you proficient with utilizing MS Project, or an equivalent, to create and maintain project schedules?
- Do you have 5 or more years in Medical device development?
- How many years experience do you have in project management?
- High school or equivalent (Preferred)
Work Location: In person