Director of Manufacturing Engineering

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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 Director of Manufacturing Engineering develops and implements short- and long-term strategies in support of company objectives.

Scope of responsibility covers new product transfer to Operations from R&D, sustaining activities in partnership with R&D for all active products and the development of new competencies, capabilities, and technologies appropriate to manufacturing operations.

The Directoroversees staff who are responsible for planning, developing, implementing, and installing production equipment, processes, tools and methods required to transfer new products to manufacturing, and to sustain the manufacturing of released products.

The Director is responsible for budgeting, staffing of the manufacturing engineering department, and for establishing systems, programs, policies and procedures that ensure ISO 13485 compliance is maintained.

Responsibilities :

• Lead, train and mentor staff, as appropriate, to ensure compliance to regulatory requirements.
• Motivate a team of engineers to achieve aggressive targets on project deliverables
• Take the lead role regarding manufacturing transfer. Work cooperatively with the Marketing, Quality, Operations, Purchasing and R&D New Product Engineering teams to prepare for the transfer of new products to production.
• Partner with R&D Engineering during product development to ensure the strong consideration of DFx (Design For Manufacturing / Assembly / Service) and supplier cost / quality / capability.
• Practice and train team members on Lean Manufacturing tools (process mapping, demand flow technology, product Poka Yoke, etc.)
• As a senior member of the Operations staff help create and deploy creative strategies that advance the capability of the Operations team.
• Collaborate with other Mizuho engineers on electro-mechanical designs, and activities concerned with technical developments, scheduling, and resolving engineering design and test problems within standard regulations.
• Work directly with Operations / Assembly to successfully launch new products, giving consideration to training, facility layout, utility requirements, effective workflow and capacity planning.
• Lead the manufacturing risk assessment effort and direct the creation and update of Process Failure Modes Effects and Analysis (PFMEA).
• Specify the methods, sequence and description of operations, shop routing, time standards for each operation, and the specification for required tools and fixtures.

along with the verification and / or validation test documentation.

• Develop, update and maintain manufacturing and test documentation that ensures consistent assembly and testing of products.
• Participate in MRB activities to disposition rejected materials and mitigate future non-compliant issues.
• Support manufacturing and assembly activities by resolving ad hoc problems, developing appropriate tooling and fixturing to improve product consistency, and quality.
• Work cooperatively with Purchasing and Quality to assess suppliers’ and subcontractors’ capabilities, and to resolve technical issues regarding received components, materials and services.
• Pursue cost improvements on existing products through rigorous analyses of processes, procedures, materials and design.
• To understand Mizuho OSI’s business objectives and the relationship between the Department and those objectives; to support and follow the Corporate Vision, Mission & Values Statements, to maintain the services and quality levels set by Mizuho OSI, and to continually enable Mizuho OSI to be a great place to work.
• To 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 :

• Bachelor’s degree in electrical engineering, mechanical engineering, or related field. A minimum of ten (10) years of manufacturing engineering experience with at least four (4) years in a management capacity or equivalent combination of education and experience.
• Strong technical background with thorough knowledge of manufacturing processes and materials in a medical device environment preferred.
• Excellent creative, innovative and results oriented project management skills.
• Strong use of Microsoft Office (e.g., Excel, MS project, Word). Familiar with a 3D solid modeling package, preferably Solid Edge, Solid Works, and AutoCad software.
• Proven hands-on experience with QSR / ISO 13485 medical device requirements preferred.
• Ability to lead, motivate and develop staff.
• Goal driven independent thinker, equally capable as an individual contributor or team leader.
• Excellent written and verbal communication and interpersonal skills.
• Expertise in Lean Manufacturing methods.
• Excellent computer skills including operating Windows based personal computers, various office equipment and machines, and telephone system.

Ability to efficiently and effectively use Microsoft products such as Outlook, Word, Excel, and PowerPoint.

Ability to function calmly in a fast-paced environment managing multiple priorities simultaneously. To 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.

• Respond sensitively to the needs and feelings of others regardless of position; to accept interpersonal differences, to maintain rapport, and to interact effectively with all levels of employees within the organization.
• Able to demonstrate an understanding, and the regular use of a time management process, which systematically structures one’s own work to provide for effective task performance and to plan and prioritize items to meet future demands.
• Ability to establish and accomplish goals independently and to function as a positive and productive team member.

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

Salary : $161,810.60 - $231,158.00 Plus Bonus

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, criminal convictions, 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 (510) 429-1500.

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 (510) 429-1500.

Nearest Major Market : San Francisco

Nearest Secondary Market : Oakland

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