Manager, Soft Goods Engineering

Mizuho OSI; Union City (CA); On-site; USD 160,000 - 184,000; Full time

Job summary

Mizuho OSI, a leader in specialty surgery and patient positioning, seeks a Manager of Soft Goods Engineering to guide a team of R&D professionals. You will oversee design, development, and testing of OR soft goods, including drapes, covers, and patient surfaces, ensuring alignment with project goals and regulatory standards.

The role requires strong leadership and manufacturing knowledge, with a focus on driving cross-functional collaboration and continuous improvement in a fast-paced

Qualifications

• Bachelor's degree in Mechanical, Industrial, Biomedical, or Materials engineering.
• Five to eight years of design experience with emphasis on medical product design.
• Four years’ experience in a supervisory capacity preferred.
• Proficiency in CAD software, including SolidWorks; working knowledge of soft goods design tools such as Rhino and CLO.
• Prior medical device experience strongly preferred.
• Experience with soft goods design and manufacturing, including textiles and sewing/stitching.
• Experience designing operating room products such as disposable drapes, equipment covers, patient supports and pads.

Responsibilities

• Provide leadership to the engineering team by inspiring them and aligning around the organizational goals.
• Lead soft goods engineering design for operating room products including disposables drapes, equipment covers, and patient support surfaces.
• Plan and manage engineering activities collaboratively with stakeholders.
• Review product designs for compliance with QMS, regulatory standards, and customer requirements.
• Develop and mentor employees, providing feedback and coaching as needed.
• Coordinate with HR on staffing, onboarding, and performance management.

Skills

Leadership

Communication

Project management

Manufacturing

Education

Mechanical Engineering

Industrial Engineering

Biomedical Engineering

Materials Engineering

Tools

SolidWorks

Rhino

CLO

Job description

About Company

Mizuho OSI is the leader in the markets for specialty surgery and patient positioning. The company’s portfolio includes specialty surgical tables for procedure-specific approaches that improve patient outcomes in spine and orthopedic surgeries along with disposable and reusable surgical patient care products.

About Company

Mizuho OSI is the leader in the markets for specialty surgery and patient positioning. The company’s portfolio includes specialty surgical tables for procedure-specific approaches that improve patient outcomes in spine and orthopedic surgeries along with disposable and reusable surgical patient care products.

Job Summary

The Manager, Soft Goods Engineering, leads a team of R&D professionals who are responsible for the work production and quality of work in the design of operating room soft and durable equipment. The Manager participates in program planning and will assign resources to drive projects to completion. This position possesses and applies comprehensive knowledge of the soft and durable goods engineering field.

The Manager, Soft Goods Engineering, is responsible for aligning around a clear vision and purpose while leading, inspiring, developing and motivating the team to successfully achieve individual and organizational objectives.

This position exercises a high degree of independent judgment on diverse and specialized projects. This position has oversight of exempt and non-exempt staff working in engineering functions including but not limited to: Soft Goods Engineers, Mechanical Designers, and Technicians.

Responsibilities

• Provide leadership to the engineering team by inspiring them and aligning around the organizational goals.


• At times, may be required to act as a lead soft goods engineer designing operating room products including disposable drapes, equipment covers, patient support surfaces such as pad designs, electro-mechanical smart devices, user touch point covers (patients, physicians, and support staff).


• Create and maintain a work environment that fosters a sense of purpose, urgency, involvement, engagement, and accountability.


• Manage the soft goods engineering team by planning, delegating, training, monitoring and reviewing their work.


• Review product designs for compliance with DFM/DFA engineering principles, company quality and regulatory standards, customer requirements, and technical specifications.


• Evaluate and approve design changes, specifications, and drawing releases.


• Plan and execute engineering activities collaboratively with stakeholders.


• Work with key core teams in other departments to release new products, sustain and enhance legacy products, and drive cross functional process improvements


• Work with other functional managers, leaders and R&D program managers across the organization to coordinate program resources and project schedules.


• Plan and execute soft goods engineering activities collaboratively with stakeholders.


• Mentor and develop employees giving timely and constructive feedback, explaining rationale and thought process to help employees improve their skills.


• Support change management of new methods, procedures, and techniques for department, organizational and cultural changes.


• Construct professional development plans and monitor the progress encouraging team members to pursue development opportunities.


• Train employees on safety, work instructions, and good engineering standards and procedures. Ensure a safe work environment is provided and immediately investigate and resolve any hazards.


• Develop soft goods including disposable and durable components and products to meet Mizuho’s operating room equipment cost, manufacturability, serviceability, and reliability targets.


• Communicate openly, clearly, proactively, and positively to inform and engage employees in a diverse environment.


• Work closely with Human Resources to resolve employee relation activities, including hiring, on-boarding, training, performance management, coaching, disciplinary actions, leaves of absence, and separations from employment.


• Understand, follow, and support Mizuho OSI’s internal Quality System policies, procedures and work instructions including but not limited to applicable external regulations (21 Code of Federal Regulations Part 820 Quality System Regulations and applicable International Standards).

Qualifications & Requirements

• Manager: Bachelor’s degree in Mechanical, Industrial, Biomedical, Materials engineering or related field; five to eight years of design experience with emphasis on medical product design; four years’ experience in a supervisory capacity preferred; or equivalent combination of education and experience.


• Proficiency in CAD software, including SolidWorks, with working knowledge of soft goods design tools such as Rhino and CLO.


• Demonstrated technical depth and experience reviewing engineering work products, including engineering drawings and specifications, mechanical tolerance analyses, test methods/protocols, design verification activities, and technical documentation to ensure sound engineering rigor and compliance with design requirements.


• Prior medical device experience strongly preferred.


• Experience with soft goods design and manufacturing strongly preferred, including knowledge of textiles, foams and flexible materials, sewing/stitching and assembly methods, pattern development, material construction, and design for manufacturability.


• Experience designing operating room products strongly preferred, including disposable drapes, equipment covers, patient support surfaces and pads, electro-mechanical smart devices, and user touch-point covers.


• Demonstrated ability to lead, engage, motivate, and develop employees directly reporting to this position as well as cross functionally


• Skilled in organizational influence with internal and external customers.


• Demonstrated experience identifying and driving engineering process improvements to increase efficiency, quality, consistency, and overall team effectiveness.


• Excellent customer focus with a high sense of urgency. Ability to provide excellent interpersonal and communication skills.


• Highly professional and consistent exercise of good judgment while maintaining a high level of confidentiality and sensitivity at all times. Must be able to think strategically and function tactically and positively creating a highly productive work environment.


• Ability to function calmly in a fast-paced environment while managing multiple priorities simultaneously. Be able to positively manage situations of a dynamic nature; to be able to modify plans, actions, and decisions in light of changing situations and circumstances while still meeting, or proposing modified, deadlines.


• Excellent verbal and written communication skills, strong presentation, project and organizational skills.


• Respond sensitively to the needs of others regardless of position; to accept interpersonal differences, to maintain rapport, and to interact effectively with all levels of employees within the organization.


• Ability to apply principles of logical or scientific thinking to define problems, collect data, establish facts, and draw valid conclusions.


• Ability to gain cooperation of other functional groups within the company, establish and maintain good working relationships with both internal and external partners.


• Excellent facilitation skills, including the ability to create presentations and facilitate effective group presentations. Must be effective in presenting materials internally, externally, and at senior levels, including Executives.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Salary range: $160,000 - $184,000 DOE + annual potential bonus + comprehensive benefits package