Manager, Supplier Engineer

San Jose, CA - USA

Monthly Salary: Not Disclosed

Posted on: Yesterday

Vacancies: 1 Vacancy

Department:

Operations

Job Summary

Company Overview

Embark on an enriching journey with PROCEPT BioRobotics where our vision mission and values guide everything we do as a company. At PROCEPT we put the patient first in everything we do andare 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.

SUMMARY

Responsible for ensuring suppliers meet Procepts 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 metals processing machining electronics PCBA plastic injection molding experience etc.

CORE RESPONSIBILITIES (Other duties may be required as assigned)

Own and manage contract manufacturer and supplier qualifications of components sub assemblies used in Aquablation capital equipment components disposables and accessories as assigned. Typical parts include mechanical machined components molded components electronics electro-mechanical and camera systems.
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 Procepts 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 suppliers 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.

QUALIFICATIONS (Education Experience Certifications)

BS in Mechanical Engineering or equivalent with a minimum of seven years experience.
Brings 1-2 years of managerial experience leading other supplier engineers.
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.
Experience with metals component manufacturing processes. Understanding of metallurgy metals material selection secondary processes such as heat treatment anodizing deburring passivation etc.
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.
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 and 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.

$162000 - $191000 a year

Compensation also includes a 15% annual bonus flexible time off and RSUs at offer!

Understanding PROCEPTs 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 doesnt happen by accident. It starts with our live induction program that serves as an incubator for cross-functional team building an immersion in Procepts 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 wont 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!

PROCEPTs 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

Well 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.

PROCEPT BioRobotics Applicant Privacy Notice

When you submit an application on this site PROCEPT BioRobotics collects the personal information you provide. This may include your name email address phone number résumé or CV LinkedIn profile and any optional demographic information you choose to share such as gender or ethnicity. We use this information to review your application and assess your suitability for the role.

To learn more about how we handle personal information including your rights under applicable privacy regulations please read our full Privacy Notice at: .

We may use artificial intelligence (AI) tools to support parts of the hiring process such as reviewing applications analyzing resumes or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed please contact us.

Required Experience:

Manager

Company OverviewEmbark on an enriching journey with PROCEPT BioRobotics where our vision mission and values guide everything we do as a company. At PROCEPT we put the patient first in everything we do andare committed to revolutionizing treatment for benign prostatic hyperplasia (BPH otherwise known...