Project Manager 2

Date:  Sep 12, 2022
Category:  Research and Development
Location: 

Union City, CA, US

The Project Manager coordinates, plans, organizes, and manages material and human resources to drive successful completion of assigned medical device engineering projects. The position defines problems, collects data, establishes facts, and draws valid conclusions to make sound recommendations and decisions based upon cost, customer requirements, regulations and other pertinent data.

The Sr. Project Manager ensures that product designs meet specification and function as intended. The position oversees projects through all phases of development to include initiation, planning, design, test, market launch, production transition to NPI, monitoring and closing. The position ensures projects meet project goals on time, on budget, with high quality.

 

We are looking for you, if you have the ability to:

  • Effectively convey vision, ideas, goals, and issues—as well as produce reports and presentations, among other skills.
  • Manage and coordinate groups of individuals by promoting teamwork, delegating tasks, resolving conflict, setting goals, and evaluating performance.
  • Inspire others to walk with you
  • Negotiate the use of resources, budgets, schedules, scope creep, and a variety of other compromises that are unavoidable
  • Get things done and organize work for other people
  • Predict and create solutions to issues before they arise
  •  

Here is what you will do day-to-day:

  • Ensure projects are consistent with corporate quality and regulatory policies.
  • Build cohesive engineering project teams and cross functional program teams. Provide the leadership necessary to motivate employees and meet company defined deadlines.
  • Coordinate and complete projects across functional areas (Marketing, Quality & Regulatory Affairs, Purchasing, Operations). Coordinate with functional management to allocate appropriate human resources based on project needs and schedule for the project.
  • Identify risks and address corrective actions.
  • Maintain complete, accurate, and timely design history documentation as required.
  • Contain product cost through design, process, procedure, and method improvement.
  • Review product design for compliance with engineering principles, company standards, customer contract requirements, marketing requirements, and other related specifications.
  • Evaluate and approve design changes, specifications, and drawing releases.
  • Assist Engineers and Designers with technical input as necessary.
  • Create comprehensive cross-functional project plans that include conceptual design, specifications, critical path items, FMEA, risk analysis. Collaborate with appropriate functional groups for financial analysis and budget, product cost, tasks, deliverables, schedule as well as product marketing, forecast and launch plans, product production and product service plans.
  • Manage project teams to comply with medical device design control requirements of FDA and ISO 13485.
  • Identify and resolve project management issues within the team. Guide the team to plan and schedule project timelines and milestones.
  • Communicate effectively the project goals and objectives.
  • Monitor project activities, progress, milestones, and cost to ensure new products release in accordance with company’s long-term strategy.
  • Report project(s) status on a weekly basis to corresponding departments and communicate with management on a regular basis.
  • Escalates budget and schedule issues as appropriate.
  • Train and instruct other members of the department and the company, by passing along skills and information to assist them in their development and advancement either with one-on-one or with platform training skills.
  • Become an independent employee able to analyze problems and formulate plans to overcome challenges and to get work done quickly with a high degree of quality. Make sound and logical decisions and choose the appropriate courses of action based on the parameters of the situation at hand and to use continual improvement problem solving skills.
  • Create an ongoing effort to improve the Company and the Project Engineering department through personal action and by contributing ideas to support both the department and Company’s ongoing improvement efforts.
  • Understand, follow and support Mizuho OSI’s internal Quality System policies, procedures and instructions including but not limited to applicable external regulations (21 Code of Federal Regulations Part 820 Quality System Regulations and applicable International Standards).

 

MINIMUM QUALIFICATIONS

EDUCATION AND EXPERIENCE:

  • Master's Degree in a technical or engineering related field with at least 4 years of related experience OR
  • Bachelor's Degree in a technical or engineering related field with at least 6 years of experience

 

KNOWLEDGE, SKILLS AND ABILITIES:

  • PMP Certification is highly desirable. Agile Scrum methodology is highly desirable.
  • Knowledge of Six Sigma is a plus.
  • Thorough knowledge of medical device design documentation regulations.
  • Demonstrated ability to lead specific engineering project teams.
  • Strong influencing skills: ability and judgment to provide project management direction to the team, to ensure project plan is executed.
  • Project management experience with responsibility for multifunctional disciplines.
  • Knowledge in areas of schedule development, cost, scope, system integration, and quality assurance.
  • Ability to apply principles of logical or scientific thinking to all aspects of the job.
  • Neat and professional appearance and outgoing people-oriented personality which conveys pride in working for Mizuho OSI and which is demonstrated with a ready smile and a willingness to assist others.
  • 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 clearly express oneself verbally in the English language using good grammar, vocabulary, eye contact, and friendly voice inflection with all employees. Ability to communicate effectively with employees and other business contacts in a courteous and professional manner. Excellent verbal and written communication skills, persuasive communication, strong presentation, meeting management, project and organizational skills.
  • Ability to express oneself clearly and effectively through written means, to properly use such technical factors as grammar, punctuation, vocabulary, and correct spelling. To be able to prepare business letters, and reports. Ability to perform basic arithmetic functions, create and reconcile reports, demonstrate strong analytical skills, and attention to detail.
  • Excellent customer focus with a high sense of urgency. Ability to work with a professional and positive attitude to improve processes.
  • 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.
  • 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.
  • Ability to establish and accomplish goals independently and to function as a positive and productive team member.

 

What you need to be prepared for: 

The physical demands are representative of those needed to perform the essential functions of the job in an office environment. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

NOTE: This job description in no way states or implies that these are the only duties or functions to be performed by the incumbent. Employees will be required to follow any other job-related instructions and to perform any other job-related duties/functions requested by their supervisor.

 

 

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.

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.

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