R & D Project Manager

Company: Onward Technologies Inc
Location: Redwood City
Posted on: May 5, 2022

Job Description:

Title: R & D Project Manager
Location: Redwood City, California

Job Description:
This role within the R&D group is responsible for leading our client's project management activities. The position manages projects adhering to our client's internal design controls while working cross-functionally advancing development, prototypes, testing, documentation, and production transfer as well as management of external development and manufacturing resources. The position works closely with, and in compliance to, quality management system (QMS) and applicable global regulations. The Senior Project Manager provides project leadership and structure to engineering teams in the development and implementation of new solutions for current and future product lines and manages support from various inter-departmental contributors.

Responsibilities: (Other duties may be required as assigned)

Project Management - Actively leads R&D projects (Software & Hardware) from planning through deployment by driving adherence to design controls, key development milestones and schedules; collaborates cross-functionally with the technical and specialist teams as well as other project managers to identify interdependencies across various projects and advances tools and processes utilized by the organization to drive efficiencies; mentors less experience members of the team including new Project Managers; Sets, manages, and reports on project budgets within departmental budgets.
Resource and budget management - Instrumental team member for driving alignment on identification and prioritization of resources and budgets across all projects.
Sustaining Engineering and New Product Development - Management of projects that are both (1) enhancements to the existing generation of the Aquablation System and related accessories and (2) Part of the evolving roadmap of future product and platforms from conception to commercialization.
Cross-functional leadership - Drives collaboration between multidisciplinary stakeholders and subject matter experts; leads projects requiring inputs and deliverables from adjunct department contributors.
Risk Management - Solicits inputs from development team and stakeholders on project and product risks; anticipates, captures, and dispositions risk through the project risk registry or RAID (risks, assumptions, issues, and dependencies) log; contributes to risk management activities and documentation.
Requirements - Collaborates with marketing, systems engineering, technical functions, clinical, quality and regulatory teams to support the development of product requirements and specifications.
Reporting - Responsible for regular project status updates to both the development team and key stakeholders and leaders; manages the project dashboard by regularly updating progress, milestones, risks, scope and deliverables; collaborates with other project managers and department leadership on regular reporting to the Executive Steering Committee.
Development planning - Responsible for generating and maintaining the project schedule, monitoring progress, and directing resources; works with stakeholders, Product Owner/Manager and development team on Agile and Phase Gate development planning; manages Agile product backlog, daily scrums, reviews and retrospectives; manages phase gate development processes; designs Agile sprints, epics and stories along with Phase Gate development plans in accordance to BioRobotics' design controls procedures.
Quality/regulatory - Owns the responsibility for Design History File (DHF) and Device Master Record (DMR), supporting compliance to the QMS and regulations, leading design reviews, managing controlled documentation and supporting audits; leads documentation management and release in support of domestic and international regulatory approvals; assists in any technical trouble shooting associated with complaint processing, CAPA resolution and execution.
Supply chain - Develops and maintains relationships with established and new suppliers - domestic and international; sets up projects with fabrication contractors for components or assemblies; ensures suppliers have adequate quality systems, good manufacturing practices, manufacturing process control and that they can meet requirements for regulatory compliance and produce products to quality standards.
Verification and validation - Plans and coordinates testing to assess feasibility of new products, trouble shoot existing issues and verify requirements; works cross-functionally on the development of protocols, builds, procurement, testing, reporting and documentation release.
Quality Management System - Maintains trained status for, and complies with, all relevant aspects of the Quality Management System to ensure product and support regulatory compliance.
Quality Policy - Understands and adheres to the Quality Policy.
Environmental Health and Safety (EHS) Policy - Understands and adheres to the EHS Policy.

Qualifications (Education, Experience, Certifications):
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

BS degree with 8+ years' experience or MS degree with 6+ years' experience in technical project management related to the development of medical electronic devices comprising a combination of mechanical, electronic, integrated circuit, software and embedded system design
Experience working in a structured design process such as ISO 13485 or FDA QSR, knowledge of regulatory approval process and requirements
Previous technical project management experience using established frameworks such as AGILE and Kanban a plus
Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from other internal groups, clients, customers, and the general public.
Ability to work as part of a multi-disciplinary team in a small, fast-paced company
Ability to balance hands-on detailed design tasks and project management/planning functions
Strong written and oral communication skills
Strong interpersonal skills. Needs to have the ability to manage and influence vendor engineering teams outside of the office.

Keywords: Onward Technologies Inc, Redwood City , R & D Project Manager, Executive , Redwood City, California