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12637BR

Title:

Staff Systems Engineer, R&D

Job Description:

As a technical leader, responsible for the feasibility, design, and development of capital equipment and accessories needed to deliver an advanced therapy through a single-use device. Architect the system by evaluating components in technical feasibility, building bench-level prototypes, and conducting experiments to lead the understanding of system and sub-system design requirements. Translate new ideas into high-level design concepts and prototypes. Engage in the full product lifecycle, from inception to final product realization. Work collaboratively within a Team and with customers, Marketing, and other stakeholders to translate customer needs to products. Job description:

+ Work in cross-functional teams to identify customer needs and develop systems and specifications to meet those needs.

+ Translate abstract ideas into design solutions using variety of methods.

+ Communicate technical concepts effectively to non-technical team members to facilitate cross-functional understanding.

+ Architect, build, test, and troubleshoot systems and sub-systems.

+ Conduct lab experiments, collect and analyze data, document, and present results.

+ Work with manufacturers to define requirements for components and subsystems and realize prototypes.

+ Work with the team to develop product design requirements based on top-level requirements and user needs input.

+ Develop system specifications, test plans, protocols, and reports for designs.

+ Collaborate with Quality Engineering on the drafting of system level risk management documents (i.e., FMEAs).

+ Train technicians to assemble and test systems, sub-systems, and components.

+ Develop and maintain vendor relationships.

+ Interface with appropriate internal and external resources to ensure intellectual property is appropriately protected.

+ Comply with applicable Laws and Regulations, adhere to Quality Management System processes and requirements as well as demonstrate Ethics and Integrity in all matters and at all levels throughout the organization.

+ Perform additional duties as assigned.

Auto req ID:

12637BR

Location MV:

Aliso Viejo, California, USA

Department Name:

800-California Interventional Systems (CAIS)

Qualifications:

1. Bachelor’s degree in engineering or related scientific field.

2. Minimum six (6) years of related work experience.

3. Strong written and verbal communication skills.

4. Hands-on experience with product development and assembly of capital equipment.

5. Familiarity with industry standards, including, but not limited to, ISO 13485 and IEC 60601.

6. Working knowledge of fundamental engineering principles across multiple engineering disciplines (e.g., electrical, mechanical, software, etc.).

7. Strong design expertise using CAD (ideally SolidWorks), including the ability to generate complex designs with clean and organized design history, detailed 2D drawings, and BOMs.

8. Proficient computer skills including MS Word, Excel, PowerPoint, Outlook, and Teams.

Desired Qualifications

1. Advanced degree in engineering or related scientific field.

2. Technical leadership experience in developing medical device capital equipment from concept to commercialization by managing system level requirements, specifications, risks, and design outputs.

3. Strong debugging and root cause analysis skills with new, unique problems as they pertain to testing designs, product use, and manufacturing processes.

4. Industrial design experience with capital equipment.

5. Successful supplier management experience with a contract manufacturing partner.

External-Facing Title:

Staff Systems Engineer, R&D

Posting Country:

US - United States

Salary Range:

111,000 - 145,800 (Compensation could be higher/lower based on experience, education and skill sets)

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, ethnicity, disability, religion, national origin, gender, gender identity, gender expression, marital status, sexual orientation, age, protected veteran status, or any other characteristic protected by law.