Company Overview
Embark on an enriching journey with PROCEPT BioRobotics, where our vision, mission, and values guide everything we do as a company. We are committed to revolutionizing treatment for benign prostatic hyperplasia (BPH, otherwise known as prostate gland enlargement) through innovation in surgical robotics. As our company succeeds and grows, we improve the quality of life of patients, provide more effective treatment options for surgeons, uphold the trust of our shareholders. That starts with a commitment to our People with a focus on creating an evolving landscape for your career, brimming with transformative opportunities that provide continuous career growth opportunities.
The Opportunity That Awaits You:
Are you ready to embark on an exciting journey with PROCEPT BioRobotics?
As we continue to grow and scale our operations team at PROCEPT, we have an excellent opportunity for a new Senior Supply Engineer who is Rresponsible for ensuring suppliers meet Procept’s requirements for quality, service, delivery, and cost. Drives suppliers to continuously improve business and manufacturing processes. Collaborates with Supplier Quality to evaluate and select suppliers. Guides R&D in choosing suppliers for new products and provides DFM input to new designs. Supports both NPI and on-going production, monitoring and working with suppliers to improve supplier performance. Executes detailed projects with suppliers to implement changes and improvements affecting quality, cost, capacity, risk, and sub-supplier management.
The ideal Candidate possesses broad and deep manufacturing experience for processes such as assembly of medical devices, machining, plastic injection molding experience etc.
What Your Day-To-Day Will Involve:
- Own and manage supplier qualifications of components, sub assemblies used in Aquablation disposables and accessories as assigned. Typical parts include mechanical machined components, molded components, electronics, electro-mechanical and camera systems, packaging, labels and IFU’s.
- Assess and drive supplier qualification requirements and complete project/ part qualification deliverables including: Supplier pFMEA, Process Validations (IQ/OQ/PQ), Inspection Reports, Gage R&R, and Process Capability Analysis.
- Manage and coordinate problem solving and root cause identification for parts not meeting requirements or specifications.
- Review and approve supplier protocols, qualification reports. Release documentation and reports in Change management systems (ECO).
- Develop supplier ramp readiness plans by judging business risk based on forecast, supplier capacity, quality performance, and process capability. Identify supply capacity gaps and develop plans to mitigate (capacity expansions, qualification of additional tooling, lines etc to meet target business plan capacity).
- Manage supplier changes (for mechanical parts/assemblies) including manufacturing process changes, production optimization, facility changes, new equipment qualification, and new line validations.
- Work with suppliers to execute cost reductions, capacity improvements, and risk mitigation.
- Generate key metrics for the suppliers, and continually drive for timely achievement of those metrics.
- Drive suppliers to continually improve their manufacturing process performance to meet Procept’s requirements for supplier excellence using a collection of best practices in project management, Six Sigma, Lean, SPC and negotiation. Lead these efforts without managerial guidance at several suppliers simultaneously.
- Investigate and drive rework, corrective actions for purchased part raw material non-conformance
- Work closely with supplier quality team to develop and implement corrective and preventive actions for supplier processes by driving supplier’s investigations and root cause analysis.
- DFM by engaging suppliers early in development cycle to provide feedback regarding manufacturability improvements in the designs prior to production.
- Effectively prioritize and advance multiple concurrent projects and tasks.
- Research and recommend new technologies to improve reliability, efficiency and contribute to cost reduction.
- Maintain trained status for, and comply with, all relevant aspects of the PROCEPT BioRobotics Quality Management System to ensure product quality and support regulatory compliance.
- Understand and adhere to the PROCEPT BioRobotics Quality and EHS policies.
- May require up to 20% travel, domestic and international.
The Qualifications We Need You to Possess
- To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- BS in Mechanical Engineering or equivalent with a minimum of seven years experience.
- Prior experience in the medical device industry is preferred.
- Experience in leading highly technical projects in a cross functional environment both internally and with CMs/Suppliers.
- Demonstrable knowledge in evaluating and challenging supplier technical, quality, and business capabilities.
- Extensive experience with root cause analysis and problem solving for both technical and process issues.
- Basic working knowledge of CAD (SolidWorks or other) software.
- Ability to read and interpret detailed mechanical drawings (GD&T) and communicate technical information.
The Qualifications We Would Like You to Possess
- Ability to interpret and understand the impact of purchased part changes like alternate raw material change, supplier process change, supplier tooling change, etc. to the internal manufacturing process and design, and develop, implement/execute qualification test case.
- Experience working in a structured design process such as ISO9000 or FDA QSR, knowledge of regulatory approval process and requirements.
- Working knowledge of design control and cGMP requirements for medical device manufacturing per FDA QSR and ISO13485-2003 or ISO9001 and EN46001, including experience in auditing suppliers to these standards.
- Ability to work in a cross functional environment, lead meetings, follow up on action items, deliverables in a timely manner and meeting deadlines. Escalate issues as and when necessary.
- Ability to travel to suppliers on an as needed basis – domestic and international
Physical Demands
- The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- To perform this duty the employee must have the ability to sit or stand at and operate a computer terminal and walk or travel within the facility. The employee may occasionally lift and/or move up to 50 pounds.
WORK ENVIRONMENT:
- While performing the duties of this job, the employee is regularly working in an office environment.
- The employee will then occasionally be exposed to engineering labs, a machine shop, and manufacturing clean rooms. This environment is subject to moderate noise from machinery (IE machine shop equipment, the PROCEPT Aquablation unit, computer equipment, printers, etc.), for which proper hearing protection may be assigned and worn.
- The employee may be exposed to hazards including electrical sparking, water, and chemicals, for which proper protective equipment may be assigned and worn.
- The above statements are intended to describe the general nature and level of work being performed.
- They are not intended to be construed as an exhaustive list of all responsibilities.
Compensation also includes a 15% annual bonus and RSUs at offer!
For US-Based Candidates Only
Work Authorization Status: Citizen / Permanent Resident
For this role, the anticipated base pay range is $130,000-154,000 per year.
Plus, eligibility for a 15% annual bonus and equity/RSUs
Understanding PROCEPT's Culture
At PROCEPT, we believe every person matters. Every employee, every patient, every caregiver. Because we are here to create a revolution, and we believe in doing that by innovating everywhere with pathological optimism. We believe in being humble and highly engaged in the work we do, while also working together seamlessly for a common goal. At Procept, curiosity, ingenuity and conviction in the power technology will transform the lives of our patients and providers.
And this doesn’t happen by accident. It starts with our live induction program that serves as an incubator for cross-functional team building, an immersion in Procept’s history, jam-packed interactive sessions with executive leadership and a crash-course in the mission and purpose of what we do. It continues with our one-of-a-kind management program designed to build the best managers in the industry, where our people managers across functions come together to exchange ideas and grow, as both managers and learners, in an environment that challenges, supports and broadens.
We are fueled by the opportunity to give people their lives back. And we believe that it begins with YOU! At Procept, we push beyond just finding a work/life balance, we strive to find a work/life blend, a professional world that you are honored and impassioned to belong to, one that you can proudly share with your family, friends, and acquaintances.
An opportunity at PROCEPT BioRobotics won’t just be about finding a job. It will be an opportunity for you to join a community devoted to making a difference in this world!
BENEFITS OF WORKING AT PROCEPT!
PROCEPT’s health and wellness benefits for employees are second to none in the industry. As an organization, one of our top priorities is to maintain the health and wellbeing of our employees and their families. We offer a comprehensive benefits package that includes full medical coverage, wellness programs, on-site gym, a 401(k) plan with employer match, short-term and long-term disability coverage, basic life insurance, wellbeing benefits, flexible or paid time off, paid parental leave, paid holidays, and many more!
EQUAL EMPLOYMENT OPPORTUNITY STATEMENT
PROCEPT BioRobotics is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind on the basis of race, color, national origin, religion, gender, gender identity, sexual orientation, disability, genetic information, pregnancy, age, or any other protected status set forth in federal, state, or local laws. This policy applies to all employment practices within our organization.
PAY RANGE TRANSPARENCY
Procept is committed to fair and equitable compensation practices. The pay range(s) for this role represents a base salary range for non-commissionable roles or on-target earnings for commissionable roles. Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, relevant certifications and training, and specific work location. Based on the factors above, Procept utilizes the full width of the range. The total compensation package for this position may also include eligibility for annual performance bonus, equity, and the benefits listed above.
WORK ENVIRONMENT
We’ll provide you training for, and ask you to maintain trained status for, and comply with, all relevant aspects of the PROCEPT BioRobotics Quality Management System to ensure product and support regulatory compliance. We would also ask you to understand and adhere to the PROCEPT BioRobotics Quality & EHS policies.
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