Product Development Director jobs in Oakland, CA

Job Description

Position Title: Director of Product Development

Department: Research & Development

Reports to: Chief Technology Officer, CTO

Position Summary:

This leadership position is responsible for managing and directing a team of engineers to
achieve optimal productivity in a medical device manufacturing environment. Provide technical
direction and task assignments to team, while maintaining hands-on style and ability to
complete projects. Partner with Regulatory, Manufacturing, Quality, Sales/Marketing to timely
introduce new products to the market.

Essential Functions:

1. Experience driving product development projects through all phases of development
from concept to submission & launch, with proven results.

2. Product life cycle: manage design control; support sustaining engineering activities;
support quality assurance activities.

3. Plan and execute realization of product opportunies identified through the Strategic
Development process.

4. Strategize and execute product improvement activities in cooperation with Marketing,
Manufacturing and Quaility Assurance.

5. Experience in writing requirements, Engineering Change Orders (ECO’s), design
documentation, test protocols and test reports.

6. Ability to effectively manage workforce, resources, and cross functional teams.
Demonstrated results in dynamic environment and multiple priorities. Demonstrated
teamwork abilities and hands-on style.

7. Critical thinking and analytical skills, to focus on the most important product features,
and provide root cause analysis and mitigation direction for the team.

8. Responsible for department budget, personnel recruitment, training and development.

Other Responsibilities:

Position will be required to perform other duties as requested, directed or assigned.

May require domestic and international (including China) travel.

Education, Experience and skills required:

• Bachelor's degree in Engineering Discipline, Engineering or related field with a minimum

• Experience with all phases of development for medical devices in a FDA regulated

• Knowledge/exposure to Design Control for Medical Devices, ISO standards, System

• Understanding/Background in CGMP (Certified Good Manufacturing Practices).

• Excellent verbal, interpersonal and communication skills.

• Ability to think strategically and execute methodically.

• Strong presentation skills
  

Director of Product Development
Pg. 2

Rev. 09/23