Job Description

Job Description

This key manufacturing role will be responsible for providing engineering skills to support product and process development as well as manufacturing sustaining issues in dental and medical fields. The Engineer will have the ability to apply the latest standards and best practices in process, design, and validation of health care products. Responsibilities include developing innovative solutions in areas of new product design, developing and characterizing new robust manufacturing processes, and developing a deep understanding of the latest GMP and regulatory requirements. This individual will be required to be a proven problem solver and play a hands-on role in resolving issues as they occur. We are looking for an individual that like to self-directed who has the ability to project manage and execute on project deliverables to meet project and site goals. Mentoring other engineers will be a key part of the development

Key Responsibilities:

General

• Provides key engineering functions to sustain day to day activity in a manufacturing environment.
• Participate on product and process development for new product introduction.
• Present deliverables and finished projects to team leaders.
• Manages small and medium scale projects.
• Understands the intended use and functional requirements of dental and medical devices.
• Provides coaching/mentorship to junior engineer.

Process

• Process ownership for production and assembly operations.
• Recommends and implements process improvements for manufacturing procedures based on key performance indicators (KPIs).
• Participates in reviews of process design for compliance with engineering principles, company standards, customer contract requirements, and related specifications.
• Develops test methods using latest technology that are accurate, time-efficient, and cost-effective.
• Prepares the production "package" including work instructions, travelers, drawings, labeling, etc.
• Designs and completes equipment and process validations (IQ, OQ, PQ).
• Learns/masters common components and equipment as well as specifications, reliability requirements, and regulatory requirements
• Attends technical conferences and trade shows to develop an understanding of the latest process equipment, packaging, product treatment, metrology, materials and plan productivity.
• Supports initiatives for the development, introduction, improvement and sustainment of manufacturing processes. This includes introduction of Lean manufacturing techniques and a philosophy of continuous improvement.

Electro/Mechanical

• Supports the design and assembly of devices and equipment that blend electrical and mechanical components.
• Supports the development of equipment and devices at all stages, from concept creation to production tooling.
• Aims to optimize safety, economy, reliability, sustainability, and quality.
• Designs equipment tooling to improve machine and process efficiency.
• Makes adjustments and improvements to existing equipment to improve efficiency.
• Ensures maintenance on equipment within assigned area is up to date.
• Provides technical support for control systems utilized in the assigned manufacturing area.
• Generates accurate and controlled documents pertaining to process equipment.

Specific Knowledge & Skills:

• Bachelor’s or Master’s degree in Engineering (Mechanical, Electo-mechanical, Chemical, Physics).
• Ability to define documents such as operating and maintenance instructions, technical drawings, industrial standards and procedure manuals.
• Ability to write routine and technical reports and correspondence.
• Detail oriented, and ability to organize, document and communicate across the organization.
• Knowledge of regulatory requirements (FDA and others).
• Knowledge in GMP quality standards.
• Basic understanding of statistical concepts and problem-solving techniques.
• Experience with new product development processes from concept through full production release.

General Skills & Competencies:

• Good understanding of industry practices.
• Proficient with tools, systems, and procedures.
• Basic planning/organizational skills and techniques.
• Good decision making, analysis and problem-solving skills with ability to multi-task.
• Good verbal and written communication skills.
• Good presentation and public speaking skills.
• Good interpersonal skills.
• Basic conflict resolution skills.
• Developing professional credibility.

Minimum Work Experience:

Typically 3 to 5 or more years of increasing responsibility in terms of any applicable professional experience.

Preferred Education:

Bachelor’s or Master’s degree in Engineering or sciences (Mechanical, Chemical, Physics, Computer sciences).

Travel:

Travel typically less than 10%. Office environment.

Physical Demands and Work Environment

The physical demands and work environment characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to talk; hear; sit: and use hands to finger, handle or feel. The employee is frequently required to use one or both hands repetitively; grasp simply and lightly; and grasp with one hand only. The employee is occasionally required to stand; walk; use both hands repetitively; grasp firmly with both hands; push and/or pull; use both hands with fine dexterity; reach overhead with hands and arms; climb or balance; stoop, kneel, bend, or crouch; lift and/or move up to 20 pounds; and walk on uneven ground and between buildings. Normal 20/20 vision ability (with corrective lenses, if needed) is required by this position. The noise level in the work environment is usually somewhat quiet.

The posted range for this position is $73,132 to $114,737 which is the expected starting base salary range for an employee who is new to the role to fully proficient in the role. Many factors go into determining employee pay within the posted range including education, prior experience, training, current skills, certifications, location/labor market, internal equity, etc.​

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his position is eligible for a bonus not reflected in the posted range.​

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ther benefits available include: Medical, Dental and Vision Coverage, 401K Plan with Company Match, PTO , Paid Parental Leave, Income Protection, Work Life Assistance Program, Flexible Spending Accounts, Educational Benefits, Worldwide Scholarship Program and Volunteer Opportunities.

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