Company DescriptionAt Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints.
As a pioneer and market leader in robotic-assisted surgery, we strive to foster an inclusive and diverse team, committed to making a difference. For more than 25 years, we have worked with hospitals and care teams around the world to help solve some of healthcare's hardest challenges and advance what is possible.
Intuitive has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere. We strive to foster an inclusive culture built around diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves.
Passionate people who want to make a difference drive our culture. Our team members are grounded in integrity, have a strong capacity to learn, the energy to get things done, and bring diverse, real world experiences to help us think in new ways. We actively invest in our team members to support their long-term growth so they can continue to advance our mission and achieve their highest potential.
Join a team committed to taking big leaps forward for a global community of healthcare professionals and their patients. Together, let's advance the world of minimally invasive care.
Primary Function of Position:
The person in this role will use their understanding of project management and change control requirements in a regulated environment to plan, execute, and implement design projects within the Multiport Systems new product development department. Additionally, the ideal candidate can use their understanding of design controls to assess how design changes affect requirements, specifications, and risks.
The successful candidate will have enough technical depth to understand mechanical design as well as a passion for project execution, risk management and design control deliverables to get robust products to the market. A strong sense of shared responsibility and shared reward is required as well as a commitment to high product quality.
Roles and Responsibilities:
- Program management: Inform the implementation timelines and change control strategy of several projects depending on various factors (urgency, V&V timelines, etc.)
- Focusing on organizing, planning, and executing projects while working within provided bounds (i.e. budget, schedules, etc).
- Participate in the development, execution, maintenance, and support of design control infrastructure (dFMEAs, requirements, etc.)
- Inform design decisions based on documented product risk and design control strategy
- Work collaboratively with Process Engineering, Quality, Regulatory, and other cross-functional groups.
Required Qualifications and Skills:
- BS degree in engineering discipline, material science, physics, or equivalent
- 5+ years industry experience
- Medical device experience
- Familiarity with program management
- Experience with project management: developing timelines, assessing risk, etc.
- Experience with design controls: dFMEAs, trace reports, design controls
- Excellent written and verbal communication skills with a proven ability to present information in a clear and concise manner to various technical, business stakeholder, and leadership audiences.
- Team player, able to interface with technical SME’s and business stakeholders across multiple disciplines to reach best possible outcomes
Preferred Qualifications and Skills:
Note: The candidate is expected to have some, but not all, of the following list of skills. These are an important foundation for success in this role, but a candidate’s propensity for learning and ability to synthesize new information effectively will be considered first.
- 8+ years industry experience
- Experience leading projects, either as a technical lead or project manager
- Experience and understanding the relationship between design requirements, design inputs, and design outputs
- Experience creating or modifying dFMEAs, trace reports, functional requirements, etc.
- Experience with medical device regulations, both US and OUS (e.g. FDA regulations, MDR, China PTR, etc.)
- Experience working with design control software (MKS, Polarion, etc.)
- Experience with current versions of standard authoring tools, including MS Word
- Basic proficiency in CAD to review mechanisms; SolidWorks preferred.
- Organizational skills and ability to manage deliverables under tight deadlines, set priorities, and manage time effectively
- Ability to quickly learn new tools, drive process improvement and change management.
- Demonstrated ability to understand, resolve and communicate technical and business issues.
- Travel: 10%
Due to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19. Details can vary by role.
Intuitive is an Equal Employment Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws.
We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.
Preference will be given to qualified candidates who do not reside, or plan to reside, in Alabama, Arkansas, Delaware, Florida, Indiana, Iowa, Louisiana, Maryland, Mississippi, Missouri, Oklahoma, Pennsylvania, South Carolina, or Tennessee.
We provide market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity. It would not be typical for someone to be hired at the top end of range for the role, as actual pay will be determined based on several factors, including experience, skills, and qualifications. The target salary ranges are listed.
Base Salary Range Region 1: $136,500 USD - $196,500 USD
Base Salary Range Region 2: $116,000 USD - $167,000 USD
Workplace Type: Set Schedule - This job will be onsite weekly, the percentage of onsite work will be defined by the leader.