Process Engineer II - Medical Device - ATR International : Job Details

Job Title: Process Engineer II

Type: Contract- 12 Months

Day Shift

Location: 35 Cherry Hill Drive , Danvers, MA

We are looking for a Process Engineer II - Exempt for a very important client.

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: Established and productive individual contributor. Works independently with general supervision on larger, moderately complex projects & assignments. Organizational Impact: Sets objectives for own job area to meet the objectives of projects and assignments. Contributes to the completion of project milestones. May have some involvement in cross functional assignments. Innovation and Complexity: Problems and issues faced are general, and may require understanding of broader set of issues or other job areas but typically are not complex. Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area. Communication and Influence: Communicates primarily and frequently with internal contacts. External interactions are less complex or problem solving in nature. Contacts others to share information, status, needs and issues in order to inform, gain input, and support decision-making. Leadership and Talent Management: May provide guidance and assistance to entry level professionals and / or employee in Support Career Stream.

The ideal candidate will possess the following qualifications:

Required Knowledge and Experience: Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience. Requires a Baccalaureate degree (or for degrees earned outside of the United States, a degree and minimum of 2 years of relevant experience, or advanced degree with 0 years of experience.

Top 3 technical skills that are required for the role:

1. Validation Experience IQ/OQ/PQ

2. Test Method Validation

3. Problem Solving/Process Improvements

Years' Experience Required: 2+

1. Medical device design, development & manufacturing, experience of products with electrical functionality an advantage 2. Examples of critical thinking and proven project execution 3. Leading a cross functional teams and leveraging solid PM skills e.g. project planning, communication, risk management, etc. Work collaboratively and with respect & humility with a cross functional team to drive project execution for medical devices, prioritizing safety, quality service, on-time execution. Lead team to define goals, 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, Is/Is not, etc. Drive solid 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