Senior Process Engineer Medical Device

Senior Process Engineer

• Medical Device Grove Technical Resources Boulder, CO Job Details Contract $50
• $55 an hour 2 hours ago Qualifications Statistics Troubleshooting schematics Project engineering Project management in technology Quality control statistical data analysis Machine troubleshooting Statistical analysis for research Equipment troubleshooting Project management in manufacturing Manufacturing facility Production validation processes Continuous improvement Attention to detail Managing projects Technical troubleshooting support Factory experience Mechanical product validation projects Technical Proficiency Production troubleshooting Full Job Description Job Title•Senior Process Engineer•Medical Device Job Location•5920 Longbow Dr, Boulder, Colorado, United States of America, 80301 Type•W2 contract

Duration:

24 Months Technical Skills Must Have Demonstrated experience in validation. Practical 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 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.

Nice To Have:

Experience in manufacturing and/or regulated industry Experience with statistical methods. Top 3 technical skills that are required for the role: 1. Demonstrated experience in validations

IQ, OQ, PQ 2.

Demonstrated experience with running medium to large capital projects 3. Experience with statistical methods

Education Required:

Baccalaureate degree preferably in engineering (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),

Years' Experience Required:

Minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience. Job Description

• Responsibilities may include the following and other duties may be assigned.

Provide engineering support for our electron beam manufacturing line ensuring optimal operation, performance, and adherence to policy. Manage changing priorities and respond quickly to challenges in a fast-paced, dynamic manufacturing environment. Design, develop, and improve manufacturing processes, procedures, and production layouts for product assembly, equipment installation, and material handling. Work closely with R D, Quality, and other cross-functional teams to drive the integration of new technologies, process changes, and continuous improvements. Validate new components, systems, and process changes to ensure product performance, quality, and efficiency. Inspects performance of machinery, equipment, and tools to verify their efficiency, and investigates and initiates corrective action of problems and deficiencies to ensure product quality. Adapts machine or equipment design to factory and production conditions. Ensure all manufacturing processes, equipment, and procedures comply with industry regulations and standards, with a focus on maintaining safety and product integrity. Mentor and coach junior engineers and team members, providing guidance in design, troubleshooting, and process optimization.

Required Knowledge and Experience:

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 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience. Practical knowledge of project management. Strong attention to detail. Strong written and verbal communication skills. Strong technical aptitude with ability to troubleshoot complex interconnected systems, interpret schematics, and offer effective solutions. Demonstrated experience in validation. Ability to manage changing priorities and maintain productivity in a high-paced, evolving environment. Experience with statistical methods preferred. Experience in manufacturing and/or regulated industry strongly preferred. Experience with running medium to large capital projects preferred. Responsibilities may include the following and other duties may be assigned. Provides technical and sustaining engineering support for a manufacturing area utilizing electron beam technology to process material. Recommends and implements equipment and process modifications to meet quality standards and improve production efficiencies, manufacturing techniques as well as production yields for existing products. Integrates equipment and material capabilities to meet process module target specifications and technology target specifications. Reviews product development requirements for compatibility with processing methods to determine costs and schedules. Interacts with product design and development personnel to ensure that processes and designs are compatible. May develop and conduct statistical analysis or recommend additions to document work. Leads the innovation, development and/or optimization of new manufacturing concepts, processes and procedures for transfer to manufacturing operations. This can include scouting and feasibility work, material selection, process and equipment selection, tooling / fixture and equipment installation and assessment of inputs, outputs and alignment to requirements. Develops manufacturing processes that are applicable to statistical process control and may develop those techniques including the measurement systems. Ensures processes and procedures are in compliance with regulations.

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 reviewing outdated equipment systems, determining suitable alternatives then scoping coordinating and executing on replacements

• while adhering to policies, using specialized knowledge and skills.

DIFFERENTIATING FACTORS

Autonomy:

Seasoned individual contributor. Works independently under limited supervision to determine and develop approach to solutions. Coaches and reviews the work of lower level specialists; may manage projects and processes.

Organizational Impact:

May be responsible for entire projects or processes within job area. Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments.

Innovation and Complexity:

Problems and issues faced are difficult, and may require understanding of multiple issues, job areas or specialties. Makes improvements of processes, systems or products to enhance performance of the job area. Analysis provided is in-depth in nature and often provides recommendations on process improvements.

Communication and Influence:

Communicates with senior internal and external customers and vendors. Exchange information of facts, statuses, ideas and issues to achieve objective, and influence decision-making.

Leadership and Talent Management:

May provide guidance, coaching and training to other employees within job area. May manage projects, requiring delegation of work and review of others' work product.

Required Knowledge and Experience:

Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience. May have practical knowledge of project management. Requires a Baccalaureate degree (or for degrees earned outside of the United States, a degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.

Pay:

$50.00

• $55.

00 per hour

Work Location:

In person