Job Description

The Manufacturing Engineer II position supports, improves, implements and sustains optimal, cost-effective and compliant manufacturing processes in accordance with product specifications and quality standards; recommends and implements improvements to production processes, methods and controls; coordinates manufacturing launch for new or revised products. Works with suppliers to ensure seamless transactions and proper understanding of requirements. This position will be focused on manufacturing engineering support within the clean room for products that are transitioning from NPI to Commercial Manufacturing.

Essential Functions

• Designs and carries out process improvement, root cause problem solving, project management and employee training.
• Aware of DFM and manufacturing robustness of process parameters for critical processes and repeatability
• Applies engineering principles in managing, supporting, and maintaining the production of new and existing products and implementation of design changes and product improvements
• Independently works with assignments and instructions as to the general results expected.
• Generates engineering documentation (specifications, risk analysis, drawings, reports, protocols, revisions, etc.)
• Improve manufacturing processes and methods for quality improvements, efficiency and capability improvements.
• Prepares and presents detailed plans necessary to complete assigned projects. Develops schedule milestones, coordinates manpower, facility and equipment for assigned projects
• Initiates the improvement of production controls, standard operating procedures, safety, quality control and training.
• Develop manufacturing processes including production flow, assembly methods and production equipment.
• Prepares and maintains detailed layouts of buildings and equipment.
• Coordinates and manages the manufacturing launch of new/revised products including establishing goals, training team members and evaluating results.
• Designs, develops and tests as well as sources various tools, machinery and equipment for recommended manufacturing methods while providing ROI analysis.
• Performs product/process analysis for production and quality metrics.
• Represents manufacturing on cross-functional teams.
• Write engineering change orders to process changes to manufacturing documents, drawing, and Bill of Materials
• Support company finance, accounting, human resources, quality, regulatory, and clinical departments as necessary to ensure compliance with requirements.

Requirements

Education, Experience and Other Skills

• Bachelor’s degree in engineering or related and equivalent field experience
• 3+ years of Manufacturing/Sustaining experience in the medical device industry
• Strong oral and written communication skills; customer focused
• Experience with programs including SolidWorks and/or Mastercam
• MS Office Proficiency
• Problem solving skills to identify, gather, and analyze information develop solutions and resolve problems in a timely manner
• Working knowledge and experience with Quality System regulations and guidelines ISO, FDA, and GMP
• Ability to handle and be trusted with confidential and/or sensitive information.
• Able to work in a fast-paced, constantly changing environment.
• Ability to be flexible and to handle multiple projects in an organized, timely manner.
• Able to problem-solve, work under pressure, and to effectively manage stress.
• Ability to work overtime as needed.

Physical Requirements

• Prolonged periods of sitting at a desk and working on a computer.
• Must be able to lift up to 25 pounds at times.
• Must have excellent hand-eye coordination.
• Ability to differentiate between colored wires, tabs, and electronic components.
• Must wear gown, gloves, and ear protection if applicable.

of Benefits

• Group health & welfare benefits: Options for Medical, Dental and Vision insurance, Health Savings Account (requires participation in eligible medical plan), and Flexible Spending Accounts.
• Company-paid benefits: Employee Life Insurance & Accidental Death & Dismemberment (AD&D), Long Term Disability (LTD), Kavira (requires participation in medical plan).
• Voluntary, employee-paid benefits: Employee Supplemental Life & AD&D, Spouse and Dependent Life & AD&D, Short Term Disability (STD), Accident, Critical Illness, and Hospital Indemnity, Employee Assistance Program.
• Flexible Time Off Program
• Paid Parental Leave
• Paid Holidays
• Benefits and incentive compensation may be subject to generally applicable eligibility, waiting period, contribution, and other requirements and conditions.

Compensation

• The typical base pay range for this role is between $80,000-100,000/year. Compensation may vary based on individual job-related knowledge, skills, expertise, and experience. This position is eligible for a discretionary annual incentive program driven by organization and individual performance.
• 401(k) Plan: Company-provided Safe Harbor Contribution of 3% of eligible earnings.