- Computer literacy in MS Word, Excel, PowerPoint
- Investigation and root cause analysis skills, 2. Technical writing knowledge, 3. Organization and Communication skills, 4. Process Validation and Computer software validation knowledge
- 2 to 5 years
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Manufacturing Engineer II - Billerica, United States - Artech
Description
Job Title:
Manufacturing Engineer II
Job ID: 12864
Location: 880 Technology Park Drive, Billerica Massachusetts 01821
Duration: 06 Months Contract
Pay rate:
$50-$55/hr
Must Have:
" Ability to work with department peers and middle-management within the marketing, engineering, and manufacturing functional groups.
Bachelors in mechanical or industrial engineering
Catheter Assembly
data acquisition & analysis - minitab
Manufacturing Transfer Programs
Nice to Have:
comfortable to work on aggressive timeline and schedules
Good team player, fast learner, experience in medical device industry, sound knowledge of complex mechanical assembly, experience in machining processes such as polishing, milling, drilling, etc.
team collaboration
JOB DESCRIPTION
The job description that populates in VNDLY is the standard Workday description. Please provide a brief description of what the role entails.
Will execute validations (IQ/OQ/PQ) for mfg. assembly process for catheter manufacturing
Will organize builds for validation execution with operators and assemblers
Draft reports and execute statistical analysis
Understand assembly process in-detail
good process engineering knowledge
Work with custom fixtures that are electromechanical
Work in a team collaboration environment
Top 3 technical skills that you are required for the role:
experience in medical device and especially catheter mfg. environment
experience in running validations
IQ/OQ/PQ
experience with regulatory bodies and compliance for process validations
Education Required:
Years
Experience Required:
yes. Will work 40 hours/week
Does this position require the candidate to be onsite or remote, if hybrid what does the onsite vs remote schedule look like? - require to be on-site with some remote work flexibility
What is your timeline for scheduling interviews?
as early as next week
What product line will this person support?
Sphere 9 Catheters for Affera/***.
Responsibilities may include the following and other duties may be assigned. Designs manufacturing processes, procedures and production layouts for assemblies, equipment installation, processing, machining and material handling. Designs arrangement of machines within plant facilities to ensure most efficient and productive layout.
Designs sequence of operations and specifies procedures for the fabrication of tools and equipment and other functions that affect product performance.
Adapts machine or equipment design to factory and production conditions. May incorporate inspection and test requirements into the production plan.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.
Develops manufacturing processes that are applicable to statistical process control, and may develop those techniques. Provides guidance to engineering regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques. Ensures processes and procedures are in compliance with regulations.SPECIALIST CAREER STREAM:
Typically an individual contributor with responsibility in a professional discipline or specialty. 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 and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University).
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 decisionmaking.
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 University Degree and minimum of 2 years of relevant experience, or advanced degree with 0 years of experience.
Spoorthi Raj GAssociate Recruiter
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