R & D Project Manager
Company: Onward Technologies Inc
Location: Redwood City
Posted on: May 5, 2022
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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
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