Senior Process Development Engineer

INTRICON CORE VALUES:

Collaboration Innovation Velocity Authenticity Inclusiveness

POSITION SUMMARY:

The Senior Process Development Engineer is responsible for technical leadership and timely development and evaluation of new manufacturing processes to support the needs of the customer. This requires representation for the department in inter-company relations and providing technical expertise to internal clients and the customer. Senior Engineers may have direct reports and/or operate in a Lead Engineer capacity managing resources and/or small to mid-sized projects.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

1. Process Concept
   1. Proposes new process/equipment/core technology improvement concepts.
   2. Understands how user and patient needs translate to process and functional product outputs.
   3. Aids in selection of process improvements to increase UPH yield and manufacturability on pre-production and/or production products.
   4. Participates in strategic planning and department goal setting
   5. Leads phase II and process related quoting activities to support new project costing.
   6. Provides guidance on process standards templates and best practices.
2. Process Design & Development
   1. Translates customer requirements into process specific outputs.
   2. Plans and manages the development and evaluation of process assembly steps.
   3. Plans manages and conducts activities surrounding risk assessment (e.g. FMEA) of product concepts.
   4. Participates in risk assessment (e.g. DFMEA) or product concepts and translates customer DFMEA requirements to pFMEA and team.
   5. Manages process capability DOE and other characterization studies to analyze and report on results using statistical analysis.
   6. Completes engineering documentation (e.g. manufacturing and inspection procedures (MIPs) router/BOM updates etc.). to prepare and finalize documentation before verification and validation testing.
   7. Participates in project planning business case evaluation and project tracking.
   8. Leads customer meetings related to process specifics and process details.
3. Verification & Validation
   1. Manages determination of qualification requirements and criteria for new products/processes based on Intricon and customer procedures/requirements.
   2. Leads timeline planning and operations resource requests for execution of qualification activities.
   3. Prepares and releases verification/validation protocols and reports (IQ OQ PQ etc.)
   4. Leads and manages the development of master validation plan (MVP) documentation.
   5. Collaborates with other functions to execute project deliverables.
   6. Develops standard documentation methodologies.
   7. Communicates directly with customer to define validation strategy approach and constraints.
4. Work Conditions
   1. Use manual and light power tools to make and test prototypes.
   2. Works in a development lab environment in addition to office.
   3. May be in and around a tool shop.
   4. May be in a cleanroom or controlled environment area.
   5. May travel to customer or vendors for project driven objectives.
5. Working Through Others/Interpersonal Relationships
   1. Establishes extensive interdepartmental and interdivisional networks.
   2. Has an in-depth understanding of the various organizational interfaces (laboratory engineering sales and marketing)
   3. Implements comprehensive educational plans to develop maintain and expand state-of-the-art knowledge in functional area.
   4. Participates in recruiting and staffing.

*Essential Functions

PROFESSIONAL WORKPLACE BEHAVIORS:

Accountability Analytical Attention to Detail Communication Cultivate Customer Relationship Continuous Attention to Process Improvement

Embrace Differences Innovation Problem Solving/Critical Thinking Teamwork

QUALIFICATIONS:

Education:

• Bachelors degree in mechanical chemical bio-medical engineering or similar field of study or equivalent experience

Experience:

• Minimum six (6) years engineer experience in medical device industry or equivalent.
• Extensive expertise in one or several fields of the technology.

Skills:

• Experience in design controls and Quality System Regulations.
• Extensive verbal and technical writing skills

• Proven analytical and problem-solving skills.
• Strong personal interpersonal and communication skills
• Self-initiator in relation to project and/or project teams.
• Extensive command of the activities required in the product development cycle.
• Proven ability to coach/mentor people in junior positions.
• Demonstrate initiative towards introducing new technologies.
• Comfortable in ambiguity and determining necessary steps for progress.
• Interest and curiosity in differing points of view

Physical Requirements:

Physical demands described here are representative of those that must be met by an employee to successfully perform essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing duties of this Job employee is regularly required to use hands to finger handle or feel. Employee is frequently required to stand; walk; sit and talk or hear. Employee is occasionally required to reach with hands and arms. Employee must occasionally lift and/or move up to 25 pounds.

Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this position. They are not intended to be an exhaustive list of all duties responsibilities and qualifications. Management reserves the right to change or modify such duties as required.

All positions are responsible for following applicable company policies and procedures as defined by their manager.

WHY WORK AT INTRICON

We are proud to offer competitive compensation and benefits that include:

• Medical insurance
• Health Savings Account EMPLOYER CONTRIBUTIONS!
• Flexible Spending Accounts
• Dental Insurance
• Vision Insurance
• Life Insurance COMPANY PAID!
• Accident Critical Illness Hospital Indemnity Insurance
• Salary Continuance COMPANY PAID!
• Long Term Disability COMPANY PAID!
• 401k COMPANY MATCH!

Additional Benefits:

• Bonus - based on company and individual performance
• Professional Development and Degree Reimbursement
• Paid Time Off
• Employee Assistance Program / Travel Assistance
• Referral Program

SALARY RANGE:

The anticipated base pay for this position is: $95000 - $125000

Intricon is committed to providing competitive total compensation and benefits packages. This listed range is based upon a full-time schedule. This is a good faith estimate on the applicable range. Base salaries are determined by taking a variety of factors in account including but not limited to candidate qualifications education geographic locations market conditions and internal equity.

Required Experience:

Senior IC