Sr. Manufacturing Engineer

We are seeking a Senior Manufacturing Engineer that will provide leadership and decision making on large scale projects. This work will include managing project timelines and available resources. This individual will provide mentorship for the engineering team, supporting ongoing manufacturing operations and improvements. Regular support of manufacturing operations including IQ/OQ/PQ activities, risk management documentation, process development and training.

Job Duties & Responsibilities

· Generate and lead CAPEX, cost savings, CAPA related projects

· Mentor engineering team and technicians

· Define and implement Verification and Validation activities.

· Meets required schedules.

· Facilitate project plans and reviews

· Facilitate risk analysis, and implements solutions to mitigate identified risks.

· Will design manufacturing jigs, fixtures and equipment

· Write work instructions

· Create internal label specifications

· Process document change orders (DCO’s) promptly, accurately and completely.

· Support manufacturing, helping to produce products that meet Summit Medical quality standards, cost targets, and production schedules.

· Develop processes that are safe, mistake proofed, and easy to follow instructions using design for manufacturing principles.

· Support purchasing with complete documentation as required. Source, visit, and qualify vendors.

· Perform failure analysis, complete corrective actions and preventative actions as needed to support Quality

· Provides cost and expense information as required to Accounting.

· Other duties as assigned by manager.

Education & Experience Requirement

· Bachelor’s Degree in Manufacturing or Process Engineering OR equivalent work experience

· Medical device experience (3+ years)

· Team leadership and project report out proficiency

· Software proficiency: Microsoft Word, Excel, PowerPoint, Project, SolidWorks

· Manufacturing process knowledge including:

• Lean Manufacturing.
• Packaging and labeling.
• Clean room and sterilization processes

· Experience with small to large semi-automated equipment implementation including:

• Working with outside equipment manufacturers for quotes
• Design inputs
• Validations (FAT, SAT, IQ, OQ, PQ)

· Materials selection knowledge including physical properties and biocompatibility (ISO10993)

· Product Design knowledge design for manufacturing, and drafting standards

· FDA and ISO design control regulations

Preferred Skills & Abilities

· Ability to influence and advise individuals across roles and competencies

· Possess excellent verbal and written communication skills and organizational skills.

*Mechanical aptitude with capability to install, assemble, repair and maintain production equipment

Pay: $90,000.00 - $110,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Retirement plan
• Vision insurance

Work Location: In person