Design & Development Manager

SCOPE:

The Manager of D&D (Advanced D&D) provides leadership in the development of innovative products to neurosurgery instruments, provides technical support for and effectively manages and develops direct reports. Responsible for advanced research and development product and process development, resources, and project management activities associated with executing the company's goals and objectives. Main focus on early-stage, Phase 0 activities to create and refine concepts for new and innovative products.

Essential Duties and Responsibilities

Essential duties and responsibilities include, but are not limited to, the following:

• Manages, leads, and mentors engineer(s) and/or technician(s).
• Works with Marketing, Clinical, and scientific advisors as well as Key Opinion Leaders in translating clinical needs into design solutions while utilizing these resources to develop new product and/or optimize design.
• Coordinates cross-functional alignment and supports for program success.
• Leads all cross-functional project activities from concept through transfer to full product development process teams.
• Designs and develops product(s) in full compliance with the company's Design Control requirements and consistent with FDA and ISO13485 requirements.
• Coordinates technical personnel and their activities involved in developing new and improved products and manufacturing processes.
• Enhances intellectual property position of the company via invention disclosures and patent applications.
• Prototypes and develops proof of concept designs, disease models and test methods.
• Conducts new product testing, including comparison testing with competitor products, bench testing, clinical evaluation, and including protocol and test report documentation.
• Ensures that development activities are properly documented through lab notebook, history file, and other records.
• Manages outside vendors and contractors providing products or services.
• Creates, maintains, and communicates project timelines for internal and outside development projects.
• Provides regular updates of key milestones and issues to the project team as well as senior management.
• Maintains current knowledge of competitive technologies in addition to medical, technical, and biomedical developments related to company’s products.
• Contributes ideas to new products and intellectual property.
• Approves test methods, acceptance criteria, and test equipment for product development.
• Coordinates and participates in events which provide clinical feedback such as physician interface meetings, and human clinical studies.
• Ensures that products satisfy acceptable quality standards and customer needs with consensus from cross-functional.
• Reviews and approves documents as specified in Document Control SOP.
• Handles other duties as assigned.

MINIMUM QUALIFICATIONS

The qualifications below are the knowledge, skills, and abilities required to do this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

KNOWLEDGE, SKILLS AND ABILITIES

• B.S. in Engineering or equivalent work experience.
• Experience managing direct reports is preferable.
• Knowledge of QSR and applicable Quality System Standards.
• Strong understanding of engineering materials, component selection, and design for safety, reliability and manufacturability.
• Solid communication and presentation skills with level of comfort being the spokesperson and leader of a team.
• Experience taking a product from concept through clinical or commercial release.
• Ability to work in a fast-paced environment while managing multiple priorities.
• Operate as a team and/or independently while demonstrating flexibility to changing
• Employee may be required to lift objects up to 25 lbs.

PHYSICAL REQUIREMENTS

The physical demands described here are representative of those that must be met by an employee to successfully perform essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Duties are performed while sitting at a desk utilizing standard office equipment such as computer, photocopiers and telephone. Required duties include operating a computer, reading, writing and using a telephone. Walking or standing within the office, stockroom/receiving areas of the warehouse is required to check or inspect inventory products; attend meetings, and for the operation of office equipment.

Visits to hospital operating rooms may expose the employee to infectious materials – prior to these visits, the employee must prove that he/she has met each hospitals’ immunization requirements.

WORK ENVIRONMENT

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

Within the Warehouse/Production floor the employee may be exposed to sharp objects, small tools, various testing and other equipment, etc. The noise level in the work environment is usually moderate to high.

Job Type: Full-time

Pay: From $90,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Flexible schedule
• Health insurance
• Paid time off
• Parental leave
• Retirement plan
• Tuition reimbursement
• Vision insurance

Shift:

• 8 hour shift

Weekly day range:

• Monday to Friday

COVID-19 considerations:
We follow Alameda County Public Health Department policies and CDC policies for COVID-19

Ability to commute/relocate:

• Union City, CA 94587: Reliably commute or planning to relocate before starting work (Required)

Experience:

• Medical Devices: 5 years (Required)

Work Location: In person