Sr Process Engineer

JOB DESCRIPTION

HM's Top Needs:

Ability to lead their own work, think critically, and communicate clearly

TMV and IQ/OQ/PQ Experience

Previous work leading change orders, preferably in Agile, but other systems are also acceptable.

Additional detail specific to this role's immediate responsibility below.

This position will be in charge of leading the execution of equipment qualifications, test method validation and process validation changes for new product development. A self-motivated engineer with attention to detail and strong organizational and collaboration skills will be best suited to this role. This person will be working closely with process experts to create documentation and move it through the change order process. Critical thinking will be important to make sure the data is appropriately documented and able to be used to support validation efforts.

Education Required: Bachelor's Degree

Years' Experience Required: 4 Yrs Minimum

Will the contractor be working 40 hours a week? If not, weekly estimate? Yes

Work Location:

Do they need to be local to any MDT office and if so where? Yes. The location changes based on work type. The R&D facility is 2300 Berkshire Lane, Plymouth MN and Mfg Facility is 4600 Nathan Lane, Plymouth, MN

Does this person need to be on site? If so, full time or part time? The expectation is to be on-site. 3 days on site may be negotiable depending on initial performance and dependability.

Responsibilities may include the following and other duties may be assigned. Provides technical and sustaining engineering support in a manufacturing area. 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 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: 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.