Director of quality & engineering job description

PROCEPT BioRobotics is a surgical robotics company enabling better patient care by developing transformative solutions in urology. With an initial focus on BPH, the company’s AQUABEAM® Robotic System delivering Aquablation therapy, is the first FDA-cleared, automated surgical robot for the treatment of lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH). Aquablation therapy combines real-time, multi-dimensional imaging, automated robotics and heat-free waterjet ablation for targeted, controlled, and immediate removal of prostate tissue. Aquablation therapy offers predictable and reproducible outcomes, independent of prostate anatomy, prostate size or surgeon experience.

As PROCEPT continues to grow and widen its global footprint, this leadership role will be responsible for production quality control and quality engineering support for sustaining development and maintenance of our disposables and accessories production.

This role will provide quality engineering management oversight for specific elements supporting the sustenance, and maintenance of various aspects of quality systems and support any compliance related activities as required by the PROCEPT Quality Management System (QMS), which includes corrective and preventive action, training, document controls, and post market product improvements.

This role is responsible for growing, developing, and manage a high performing team to interface with various cross-functional teams across PROCEPT and support all the requisite product related quality engineering requirements.
CORE RESPONSIBILITIES (Other duties may be required as assigned)
Overall leadership of quality engineering teams that support the Disposables & Accessories operations functions. Hire, retain and lead a high-performance team that supports the relevant manufacturing operations, some of which include in-process and final quality control, sustaining quality engineering, supplier quality, design transfer of new products into manufacturing Establish and build relationships with internal and external partners to support strategic business initiatives Lead quality personnel in the completion of required departmental activities including objectives/ goal Be able to lead, execute, and implement various improvement projects Manage quality budgeting, including planning and managing to establish targets and plans Support Lean/Six Sigma initiatives on our manufacturing line Support DFX initiatives on the manufacturing line to ensure high product quality Drive R&D/Advanced Manufacturing Engineering to provide Manufacturing designs with high process capability Maintain job descriptions of subordinates. Orients new employees to the department and company Assure that the department maintains an awareness and practice of employee safety Manage and execute the overall quality engineering strategy for a particular product line or platform Drive comprehensive and detailed Program plans to successful completion Identify program risks and develop risk mitigation strategies to maintain program expectations Identify program problems and drive solutions such as allocation of resources or changing specifications Participate in formulating plans and objectives for the program area and generally review and approve projects and their implementation within the various functional areas Assure the successful transition to manufacturing and satisfactory field service support to customer as required. Travel to suppliers or contract manufacturers as needed Maintain trained status for, and comply with, all relevant aspects of the PROCEPT BioRobotics Quality Management System to ensure product and support regulatory compliance Understand and adhere to the PROCEPT BioRobotics EHS policy
QUALIFICATIONS (Education, Experience, Certifications)
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.
College Degree required, B.S. in Science, Engineering or equivalent combination of education and experience. M.S. preferred Experience working in a structured design process such as ISO13485 or FDA QSR, knowledge of regulatory approval process and requirements 10+ years of relevant experience in medical devices industry with 7 years in leadership roles Experience in managing the following standards/requirements: ISO 13485 Medical Devices – Quality Management System US FDA CFR 21 Part 820 (QSR) ISO 14971 Medical Devices – Application of Risk Management to Medical Devices Medical Device Directive (93/42/EEC - MDD) EU Medical Device Regulation (EU 2017/745) SOR/98-282 Canadian Medical Device Regulations Experience working in a fast-paced, high growth environment Proficient in project management tools like Smartsheet Strong organizational skills, detail oriented. Exceptional oral and written communication skills Experience with Microsoft Office including Microsoft Word, PowerPoint Knowledge of computer software for the analysis of data, specifically Microsoft Excel and statistical packages (Minitab preferred), is a plus. Ability to balance hands-on tasks and team management/budget planning functions Experience with electronic QMS helpful Experience working with electronic, software, and/or imaging devices is desirable Experience in understanding complex data and analyzing that data to drive the right decisions Ability to lead and collaborate within an organization across all functional departments (e.g. Legal, Regulatory, Operations, Clinical Affairs, Marketing, Quality, etc.) Excellent interpersonal and influence management skills including evidence of managing multi-disciplinary teams. Ability to work to a deadline and to handle multiple tasks simultaneously. Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write and review reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, individual contributors, and customers. Ability to apply mathematical concepts such as multiplication, exponents, logarithms, and unit of measure conversions. Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
SUPERVISORY RESPONSIBILITIES
Directly supervises employees in the Quality Department. Carries out supervisory responsibilities in accordance with the organization’s policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance, rewarding, and disciplining employees; addressing complaints and resolving problems.
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 safely within the facility. The employee may occasionally lift and/or move up to 25 pounds.
WORK ENVIRONMENT
While performing the duties of this job, the employee regularly works in an office environment. COVID-I9 Vaccine Requirement: As of August 19, 2021, all PROCEPT BioRobotics employees must be vaccinated against the COVID-19 virus. The company will follow an accommodation process for medical or religious exemptions.

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Santa Clara Valley (Cupertino),California,United States

Hardware

+ Prior experience leading large organization.

+ Prior experience with computer vision, camera or video compression, image and video processing technologies for embedded systems.

+ Team Builder: Proven track record demonstrating the ability to attract, hire, empower and develop the best managers and engineers

+ Executive Presence: Ability to summarize key points and tie them back to the customer experience and present them crisply.

+ Technically Agile: Ready to deep dive into technical areas when needed but also discuss these topics to a non-technical audience

+ Priority Driven: At ease working in a continually changing, dynamic environment and driving top issues to resolution

+ Highly organized, creative, motivated, and passionate about achieving results

+ Familiarity with test automation or continuous integration systems

**Description**

As the Director of the VE Quality Engineering team, you will be responsible for providing direction to your team members, establishing and improving validation processes and strategies to ensure exceptional quality and end user experience, driving automation efforts to improve engineering efficiency, guiding the team in design and implementation of test plans, reporting on the quality of products in development, and mentoring and coaching your team. You should be at ease working in a fast-paced, collaborative environment in which developing and cultivating partnerships with many cross-functional teams. You should also be comfortable with leading the team to test complex and new technologies.

**Education & Experience**

BS, M.S or PhD in Computer Science, Computer Engineering, Electrical Engineering, or equivalent experience 15+ years of experience in relevant fields of engineering development, quality assurance or project management.

**Additional Requirements**

+ Thrive in uncertain, rapid project schedules, being able to quickly shift priorities and maximize testing time.

+ Strive to innovate and try new things, incorporating continuous improvement of testing methods

+ Have strong interpersonal and leadership skills to make critical decisions impacting product quality and drive results from your team and external stakeholders.

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Apple is committed to working with and providing reasonable accommodation to applicants with physical and mental disabilities. Apple is a drug-free workplace. Reasonable Accommodation and Drug Free Workplace policy Learn more (Opens in a new window) .

**Role Description**

J.P. Morgan's Corporate & Investment Bank (CIB) is a global leader across banking, markets and investor services. The world's most important corporations, governments and institutions entrust us with their business in more than 100 countries. With $23.5 trillion of assets under custody and ranked #1 for Global Investment Banking fees, the Corporate & Investment Bank provides strategic advice, raises capital, manages risk and extends liquidity in markets around the world.

**Department Description**

The Cross Product Change Services Team within Corporate and Investment Bank, Digital Platform Services provides change services such as Business Analysis, Data Analytics, Process Assessment and re-engineering, Automation, Testing and Implementation support, Project management and delivery to the JPM Payments, Markets, Securities Services businesses and cross business functions like Network Management, Client Tax and KYC.

We are seeking an Executive Director (604) to spearhead overall quality and engineering operations in JPM Payments E-Commerce programs, for the Cross Product Change Services Team. This individual will be responsible for building the strategy and driving the execution of Quality Engineering practices for various Products and services

**Role Description**

Successful candidates will partner with Payments technical and domain experts; in a cross-business, cross-functional 'project' based environment. The role will provide an opportunity to work on projects across Payment's business. Additionally, successful candidates will be involved in initiatives specific focused on accelerating Org priorities. They will also have significant exposure & visibility to senior management. This role is ideal for highly motivated individuals with advanced problem solving and communications skill.

The successful candidate will join a team focused on change delivery across products, help accelerate pace of delivery, provide metrics, KPIs to enable data-based decision making and be responsible for supporting the strategy and execution of our organizational objectives.

The role will require working with stakeholders across the CIB, looking to leverage best practice across the industry and other J.P. Morgan business units. Lateral contacts in business, technology, middle offices, product and client facing organizations firm wide would need to develop and mined for best practices and driving outcome s.

**Responsibilities:**

+ Design and delivery Quality Engineering Strategy for various E-Commerce products.

+ Own and deliver on the roadmap that defines in detail how quality will be built into each SDLC stage, from ideation through continuous delivery

+ Strategy to address release management, epic validation, test environments, continuous integration and continuous testing, business process regression and test data management

+ Ensure that while "shifting-left", there is feedback from right which is being used to improve time to market for product and service releases

+ Build effective relationship with key Payment's strategy leads; whilst being able to effective challenge them to move DPS initiatives forward

+ Gathering, analyzing and synthesizing feedback from LOB interaction to help drive initiatives

+ Partner closely with Operations, Technology and Product groups.

+ Developing and syndicating recommendations to technology and program teams to accelerate change.

**Functional and Technical Expertise:**

+ Strong technical and agile delivery experience

+ Able to hold detailed conversations with technology team members about legacy, existing and new technologies that are being leverage across the CIB

+ Strong understanding of the Payments business/technical architecture

**Problem Solving and Analysis:**

+ Ability to break down analyses and issues into their individual components

+ Ability to quickly learn new concept

+ Ability to quickly derive patterns and insights from data and analysis

+ Ability to keep sight of the overall context of what they are working on and remain centered on answering the 'bigger' question

+ Superior attention to detail with eye for spotting errors and redundancies

+ Advanced financial numeracy & Excel skills

**Communication:**

+ Strong communication skills with ability to provide clear and succinct verbal updates on their work to colleagues, senior executives and clients.

+ Actively contributes to team meetings / conference calls with colleagues, stakeholders from other functions and clients / 3rd parties.

+ PowerPoint skills - able to create individual slides and structure presentations with minimal input and need for secondary review

**Working Style and Influence:**

+ Able to work comfortably & confidently under pressure and aggressive deadlines

+ Ability to work on hands-on basis and not limit oneself to only tracking and reporting milestones.

+ Ability to handle multiple work streams and manage personal time& stakeholder expectations to deliver against each

+ Safe pair of hands - keeps track of deliverables and proactively follow-ups and provides updates. Does not need to be reminded or chased

+ Is able to build relationships with and influence colleagues and LOB functions to meet deadlines

+ Ability to work collaboratively with team members and stakeholders. Not possessive about roles and responsibilities - flexible to sharing or merging roles/responsibilities with others to meet overall project or Firm objectives

+ Experienced in managing matrix teams and get the functions delivered.

+ Considerate of others, is able to take on additional work and support others during high pressure situations

**Qualification:**

+ 15+ years of project delivery experience

+ 10+ years of experience in a quality engineering / test service

+ 5+ years' experience in test automation tools and technologies

+ 5+ years of experience in Payments domain

+ 10+ years in a leadership position, where responsible for building and delivering on strategy

+ Deep Project / Test Management exposure

JPMorgan Chase & Co., one of the oldest financial institutions, offers innovative financial solutions to millions of consumers, small businesses and many of the world's most prominent corporate, institutional and government clients under the J.P. Morgan and Chase brands. Our history spans over 200 years and today we are a leader in investment banking, consumer and small business banking, commercial banking, financial transaction processing and asset management.

We recognize that our people are our strength and the diverse talents they bring to our global workforce are directly linked to our success. We are an equal opportunity employer and place a high value on diversity and inclusion at our company. We do not discriminate on the basis of any protected attribute, including race, religion, color, national origin, gender, sexual orientation, gender identity, gender expression, age, marital or veteran status, pregnancy or disability, or any other basis protected under applicable law. In accordance with applicable law, we make reasonable accommodations for applicants' and employees' religious practices and beliefs, as well as any mental health or physical disability needs.

The health and safety of our colleagues, candidates, clients and communities has been a top priority in light of the COVID-19 pandemic. JPMorgan Chase was awarded the "WELL Health-Safety Rating" for all of our 6,200 locations globally based on our operational policies, maintenance protocols, stakeholder engagement and emergency plans to address a post-COVID-19 environment.

As a part of our commitment to health and safety, we have implemented various COVID-related health and safety requirements for our workforce. Employees are expected to follow the Firm's current COVID-19 or other infectious disease health and safety requirements, including local requirements. Requirements include sharing information including your vaccine card in the firm's vaccine record tool, and may include mask wearing. Requirements may change in the future with the evolving public health landscape. JPMorgan Chase will consider accommodation requests as required by applicable law.

Equal Opportunity Employer/Disability/Veterans