Project Manager

ANEUVO • los angeles, ca, us • 4m ago

Position Description:

Aneuvo is developing breakthrough neuromodulation devices and bioelectronic medicine to treat diseases and injuries that are incurable with conventional pharmacological agents. We are building a cohesive team with complementary and multidisciplinary expertise to develop and bring our products to market.

The Aneuvo team is seeking a highly motivated individual who will be responsible for ensuring successful execution of complex interconnected projects. The ideal candidate will possess a 'bulldog-like' personality, embodying tenacity, resilience, and an unyielding approach to achieving project goals. This role requires an individual who can navigate complex project landscapes with assertiveness and persistence, ensuring that objectives are met with the highest standards of excellence.

Job Responsibilities:

Lead projects from requirements definition through deployment, planning and scheduling project deadlines.
Assemble and coordinate project timelines with teams from Product Development, Quality Assurance, Clinical Affairs, Operations, Regulatory Affairs, and Marketing.
Track project progress using appropriate tools and present project progress, problems, and solutions.
Communicate system issues to executive management and maintain positive and cooperative communications with all levels of employees, customers, contractors, and vendors.
Apply good judgment to align project actions with company strategy and apply disciplined, fact-based judgment to process improvement recommendations.
Conduct project cost analysis/control and manage technical programs, including manufacturing, scheduling, risk management, and procurement.
Stay abreast of new project management techniques, methods, and strategies, and deeply understand the medical device development, design, manufacturing, and QC process.
Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
Ensure processes are followed in accordance with all regulations (i.e., ISO/FDA/Quality, general controls).
Assist and mentor team members in following policies and procedures within the project management area.
Collaborate with and act as a bridge between multiple teams, including R&D, Manufacturing, Regulatory Affairs, Quality Assurance, Clinical teams, as well as suppliers.

Skills and Abilities

· Resourceful and versatile

· Work collaboratively on cross functional teams to establish detailed and accurate

schedules

· Strong attention to detail, deadlines and budgetary guidelines

· Excellent written and oral communication skills

· Analytical mindset:

o Ability to analyze and present data

o Ability to do basic research and present results

· Strong organizational and time management skills

· Resourceful and versatile

Minimum Qualifications

· 3 years experience as a Project Manager or similar role

· Bachelors in Engineering (Biomedical or Mechanical Engineering preferred)

· Experience working in the medical device or pharmaceutical industry

· Experience with Microsoft Project, Wrike or other scheduling tools

· Regulations (FDA 21CFR 820,ISO 9001, ISO 13485, ISO 14971, IEC 60601)/Standards (ANSI, ASTM); FMEA

· Experience managing products that are medically/clinically oriented; medical device experience preferred

· Demonstrated ability to set and meet tight deadlines and function well under pressure

· Excellent communication and interpersonal skills, ability to present to peers as well as executive management

· Ability to work in fast-paced environment and foster constructive relationships with key internal and external customers.

· Strong analytical skills

Familiar with Medical Devices, the Toxicology Industry and/or medical products manufacturing environment(s)

· Working knowledge electronic QMS system

· High level of business acumen, strategy creation, and executional excellence

Preferred Qualifications

· Professional certifications such as PMP

· High level of business acumen, strategy creation, and executional excellence

Experience working in a broader enterprise/cross-division business unit model preferred.
Ability to work in a highly matrixed and geographically diverse business environment.
Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
Ability to leverage and/or engage others to accomplish projects.
Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
Ability to multitask, prioritize and meet deadlines in timely manner.
Exhibit: Positive attitude, leadership, desire and ability to lead the organization to ensure goals achievement, deep understanding of the complexities of market and customer needs, ability to develop, rationalize, and present strategy, strong analytical and computer skills, with working knowledge of financial models, strong work ethic, self-motivation, and resourcefulness.

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