Sr Prin Quality Engineer

2 weeks ago

Warsaw, Indiana, United States LanceSoft Full time

Must Have:
1. Medical device process development and manufacturing, experience of products with electrical functionality an advantage 2. Examples of critical thinking and use of statistics 3. Working in a cross functional teams and leveraging basic PM skills e.g. project planning, communication, risk management, etc. Work collaboratively and with respect & humility within a cross functional team to establish manufacturing lines for medical devices prioritising safety, quality service, cost. Engage with team to understand goals and current reality, provide solutions and align on path forward, drive/track/communicate progress, adapt as needed with team. Read and understand quality management system documents that provide details of business processes to be used and comply with those procedures. Use scientific problem solving methodologies e.g. DMAIC, process map, 5 whys, 6M, timeline, Is/Is not, etc. Use statistical techniques to quantify confidence, declare assumptions, be data driven in decision making. Attention to detail, accuracy, to ensure own work meets required standard (compliant to quality management system, grounded in scientific facts and/or data, within safety/scope/schedule/cost guidance). Understand priority, drive critical path, and monitor secondary critical paths for progress, communicate early any challenges.
Overseeing Gage Design
Strong GD&T skills
Strong SPC acknowledge

Nice to Have:

10+ years of experience in implants process manufacturing

JOB DESCRIPTION

The role of this Quality / Process Eng is to stablish the process control needed for the manufacturing process of *** products.
This role works closely with CNC programmers to stablish the control method to satisfy the print and process requirements
To be able to perform this tasks the candidate shall have the capability of reading blue prints for which a deep understanding of GD&T is required
Also to be able to develop inspection systems with capability of satisfying print requirements and set up SPC to control the process based on historical data
Top 3 technical skills that are required for the role:
SPC
GD&T
Measurement Systems development
Process control
Education Required:
Bachelors Degree in an Engineering Discipline and at least 4 years of relevant experience or proven records of a high tech manufacturing environment providing direct manufacturing process support Or
Masters Degree in an Engineering Discipline and at least 2 years of relevant experience in a manufacturing environment providing direct manufacturing process support.
Years' Experience Required:
More than 10
Will the contractor be working 40 hours a week? If not, weekly estimate?
40 hrs a week
Does this position require the candidate to be onsite or remote, if hybrid what does the onsite vs remote schedule look like?
Hybrid model with 2 to 3 days a week on site. Also it will require to travel up to 25% of his time.
What is your timeline for scheduling interviews?
Starting January 6
What product line will this person support?
This position is not for an specific product line but will support subtract and adding manufacturing as well as extrusion and assemblies

Responsibilities may include the following and other duties may be assigned. Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product. Collaborates with engineering and manufacturing functions to ensure quality standards are in place. Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment. Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications. Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements. May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality. TECHNICAL SPECIALIST CAREER STREAM: An individual contributor with responsibility in our technical functions to advance existing technology or introduce new technology and therapies. Formulates, delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering R&D, systems or initiatives related to new technologies or therapies - from design to implementation - while adhering to policies, using specialized knowledge and skills. DIFFERENTIATING FACTORS Autonomy: Recognized master in professional discipline. Works independently to implement strategic goals and establish operational plans for job area. Assignments are often self-initiated. Determines and pursues courses of action necessary to obtain desired results. Organizational Impact: Strongly influences the design of new products, processes, standards, or operational plans based on business strategy with a significant impact on functional results. Implements strategic goals established by functional leadership. Changes or may establish operational plans for job area with long-range impact on results. Innovation and Complexity: Faces problems that span a wide range of difficulty and unique issues across functions and / or businesses which may cause redirection. Develops solutions to unique issues. Improves upon existing processes and systems using significant conceptualizing, reasoning and interpretation. Communication and Influence: Interacts with internal and external customers and vendors at various levels, including executive leadership, on significant matters. Conducts briefings with senior leaders within the job function. Negotiates with others to reach understanding or agreement. Leadership and Talent Management: Frequently provides guidance, coaching and training to other employees. Typically manages large, moderately complex initiatives of strategic importance to the organization, involving large cross-functional teams. Required Knowledge and Experience: Requires mastery level knowledge of specialty area and working knowledge of several other areas, typically obtained through advanced education combined with experience. May have deep knowledge of project management. Requires a Baccalaureate degree (or for degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.F.R. § 214.2(h)( 4)(iii)(A) and minimum of 10 years of relevant experience, or advanced degree with a minimum of 8 years of relevant experience.

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