Manager, Soft Goods Engineering

Mizuhosi; Union City, Northern (CA, KY); Hybrid; USD 160,000 - 184,000; Full time

Benefits offered by this job

Comprehensive benefits package

401k with matching

Education assistance

Job summary

Mizuho OSI is seeking a Manager of Soft Goods Engineering to lead a team of R&D professionals focused on the design of operating room soft goods and durable equipment. The role involves program planning, resource allocation, and driving projects to completion with strict adherence to quality standards.

The Manager will mentor staff, coordinate with cross-functional teams, and ensure designs meet manufacturability and reliability targets while aligning with the company’s strategic goals.

Qualifications

• Bachelor’s degree in Mechanical, Industrial, Biomedical, Materials engineering or related field required.
• 5–8 years of design experience in medical product design; supervisory experience preferred (4+ years).
• Proficiency in CAD software, especially SolidWorks; knowledge of Rhino and CLO preferred.
• Prior medical device experience is strongly preferred.

Responsibilities

• Provide leadership to the engineering team and align around organizational goals.
• Lead soft goods design for operating room products including disposable drapes and patient surfaces.
• Review designs for compliance with DFM/DFA and regulatory standards.
• Plan and execute engineering activities with stakeholders and cross-functional teams.
• Mentor and develop employees, providing timely feedback and coaching.

Skills

Leadership

CAD software

Communication skills

Project management

Problem solving

Education

Bachelor’s degree in Mechanical, Industrial, Biomedical, Materials engineering or related field

Tools

SolidWorks

Rhino

CLO

Job description

Select how often (in days) to receive an alert:

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

EOE STATEMENT

Mizuho OSI is an Equal Opportunity Employer and makes business decisions based on job related criteria only. Company policy prohibits unlawful discrimination based on race, color, religious creed, gender, religion, marital status, registered domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition including genetic characteristics, sexual orientation, sexual identity, or any other consideration made unlawful by federal, state or local laws.

Mizuho OSI conducts criminal conviction background checks and drug screening through a third-party screening vendor which includes searches of address history, criminalconvictions,court records,education verification, employment verification and reference checks. In addition, depending on the nature of the position for which you are applying, a motor vehicle driving report, a credit report, and/or ID checks in other non-U.S. countries are also included.

Criminal conviction background checks will run after an applicant has received and accepted a conditional offer of employment. After a conditional offer is made and before any background check is performed, applicants will receive background check disclosure and consent forms under state and federal laws, such as the Fair Credit Reporting Act and the Investigative Consumer Reporting Agencies Act. Existence of a criminal record is not an automatic bar to employment. An assessment will be made about whether the conviction has a direct and adverse relationship to the job in question. No job offer will be withdrawn, and no adverse action will be taken against any employee, based on the results of a criminal conviction background check, without an individualized assessment of whether the applicant’s conviction history has direct and adverse relationship with the specific duties of the job in question.

Top Reasons To Join The Mizuho OSI Team

• Privately held company with a tradition of market leadership and best-in-class innovation
• Fast-paced entrepreneurial culture focused on dramatically improving patient outcomes through personal empowerment
• Emphasis on continuous improvement and celebration of our values of R.E.S.P.E.C.T. and the Mizuho OSI Way.
• Create innovative solutions designed and manufactured at our HQ in Northern California

The Mizuho OSI Way

In 1978, we set out to change the way patients undergo surgery. As a Mizuho OSI customer, you can expect our commitment to the following…

• We commit to your satisfaction. If you are dissatisfied, we will strive to make it right.
• We do things the right way. We commit to hire people with competence, generosity and a caring attitude.
• We motivate our employees to use their individual strengths to provide creative solutions, changes, and innovations.
• We anticipate your needs through customer experiences, thus nurturing our relationships.

Collectively, this creates an environment that enables and inspires healthcare professionals to improve the lives of patients.

Dare to go further. Care to do more.

BENEFITS

At Mizuho OSI, we believe better solutions and decisions are born of diversity and are proudly an EEO/AA employer. We offer a comprehensive benefits package that includes: medical, dental, vision, life insurance, 401k with matching, educational assistance and more.

FOR OUR SERVICE MEMBERS AND VETERANS

Mizuho OSI values the service Veterans and their family members have given to our country and we support the hiring of returning Service Members and military spouses. If you are a Veteran or wounded warrior and would like assistance with the employment process at Mizuho OSI, please contact HR at [phone].

FOR PERSONS WITH DISABILITIES

If you are a person with a disability or a disabled Veteran and are applying for a job with Mizuho OSI, we would like to ensure your application process goes as smoothly as possible. If you need additional assistance, information or answers to your questions, feel free to contact HR at [phone].