Job Title: Process Engineer

Duration: 12 Months

Location: 35 Cherry Hill Drive, Danvers, MA

MUST HAVE:

• Validation Experience IQ/OQ/PQ
• Test Method Validation
• Problem Solving/Process Improvements.
• Medical Device Domain
• What product line will this person support? Sensight Reflow Process

JOB DESCRIPTION:

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.

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.