Senior Engineer, Global Services - Hybrid

DivIHN (pronounced “divine”) is a CMMI ML3-certified Technology and Talent solutions firm. Driven by a unique Purpose, Culture, and Value Delivery Model, we enable meaningful connections between talented professionals and forward-thinking organizations. Since our formation in 2002, organizations across commercial and public sectors have been trusting us to help build their teams with exceptional temporary and permanent talent.

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For further inquiries about this opportunity, please contact one of our Talent Specialists, Hema, at

Title: Senior Engineer, Global Services - Hybrid
Location: Medina, NY
Duration: 12 Months
Hours: 9 AM - 5 PM

Flexible on availability to be on-site, with someone who can work 1-2 days per week, Open to relocation and considering senior candidates. must have the ability to travel

Only W2 candidates are eligible for this position. Third-party or C2C candidates will not be considered.

Description:

Summary:

• Applies a solid understanding of engineering and problem-solving theories/practices toward the development of new or enhanced products or processes.
• Creates service deliverables and infrastructure required to support initial product launch and lifecycle management.
• Capable of designing machine tooling, jigs, fixtures, gauges and equipment used in the servicing process.
• Capable of checking designs and drawings against general standards, design requirements, geometric tolerances, drafting practices and the manufacturing process involved.
• The work of the individual should be highly creative, of high quality and offer wide latitude for independent judgment and perception with a minimal amount of supervision.
• Need not have any tools/ software experience, CAD would be a plus.
• Medical background will be a plus any regulatory background will be good.
• Someone who was worked with Engineers, multitasking will be a great fit.
• Ambiguity, adapt, multi-task and works with lead engineer in projects.
• Support the team of Product core and represent service operations and supply chain.
• Will be in charge of Service change implementation.
• Focuses on design changes, process changes.
• Collaborates with Service Process, Engineers, Technicians, impact of changes.
• Oversees Document Revision, Handle Change control, mentored and directed by team to tackle multiple product and project

Essential Duties and Responsibilities:
1. Creates new product development and lifecycle management service deliverables throughout the product lifecycle for medical device products involving hardware.
2. Supports new product platform releases. Develops and implements service training, test equipment, tools, spare parts, and service manuals / instructions.
3. Evaluates / makes recommendations on product releases related to design for serviceability. Creates (or modifies existing) servicing processes and manuals to support repair or refurbishment of fielded product at multiple global sites or in the field.
4. Works closely with design team to select, develop, and implement technologies across all medical device development programs.
5. Analyzes key servicing metrics to identify and implement opportunities for improvement in service process quality, cost, or product reliability.
6. Coordinates information flow between corporate and local/regional teams.
7. Owns Corrective and Preventive Actions related to the product(s) core team(s) supported, using sound root cause analysis.
8. May represent Technical Services on new product development and/or lifecycle management core teams.
9. May independently plan, schedule and lead cross-functional teams in detailed phases of the engineering work in a project.
10. May approve the work of lower level engineers; may supervise other engineers or technicians

Minimum Qualifications:
1. Must be well versed in core engineering disciplines (e.g. mechanical, electrical, software, systems engineering).
2. Highly motivated self-starter who is able to work with minimal supervision.
3. Must have good interpersonal and oral/written communication skills, good time management, and be capable of analyzing and solving technical problems through innovative thought and application of sound engineering principles and root cause analysis.
4. Experience with change control methodologies and configuration management principles is a plus.
5. Experience with test engineering and/or reliability engineering principles is a plus.
6. Ability to exercise independent judgment and draw conclusions based on available information.
7. Good understanding of GMP and quality system requirements.

Education and/or Experience:

• Bachelor's degree in a core engineering discipline (mechanical, electrical, software, systems, or mfg/process engineering) plus 3-5 years of experience.
• Medical device experience or other regulated industry experience preferred.
• Experience in the use of Lean Six Sigma tools highly desirable.

About us:

DivIHN, the 'IT Asset Performance Services' organization, provides Professional Consulting, Custom Projects, and Professional Resource Augmentation services to clients in the Mid-West and beyond. The strategic characteristics of the organization are Standardization, Specialization, and Collaboration.

DivIHN is an equal opportunity employer. DivIHN does not and shall not discriminate against any employee or qualified applicant on the basis of race, color, religion (creed), gender, gender expression, age, national origin (ancestry), disability, marital status, sexual orientation, or military status.

GMP, Medical Device, Lean Six Sigma