Sound Advice Consulting Services is a boutique consulting and recruitment focused on building awesome teams and helping people find work they love and enjoy. Why? Because we spent more time at work than we do with friends, family and loved ones - so you have to enjoy what you do! Colorado is our focus, but we also provide services to clients in over 30 states and half a dozen countries. Our principal objective is to provide job seekers (like you) with awesome contract consulting opportunities, direct hire/permanent placement roles at companies who are making an impact, and resume writing services that will enable you to successfully achieve both your personal and professional goals.

On the flip side, by helping build companies through people, teams, culture, support and feedback, we sit squarely in the middle and are truly able to give sound advice. We’re proactive. We pay attention to detail. We know how to connect the dots. And since 2006, that’s exactly what we’ve been doing.

About this Opportunity:
Our client is a privately held, medical equipment manufacturer committed to enhancing the science of bone repair. Over just a few short years, they have experienced unparalleled growth and market penetration. They are looking for a Product Development Engineer for their Westminster, CO office.

Job Summary:
The Product Development Engineer is responsible for designing and developing products that incorporate client's peptide technology platform. This development activity should be done in consort with input from various stakeholders, including the commercial team, operations, and quality. In addition to product development activities the candidate will need to develop new manufacturing methods and quality control test protocols and/or modify existing test methods to ensure that the new products can be manufactured and packaged in a manner consistent with industry norms.

Specific Functions and Responsibilities:

• The candidate should be able to work independently, planning a reasonable course of action that incorporates published information and practices into the development program.
• The candidate must be capable of documenting their work sufficiently well so that the research and development activities can be preserved, understood by others and used in support of any patent activities that might arise from the work.
• The candidate must be able to communicate verbally sufficiently well to be able to interact with other team members and outside contract research organizations.
• Coordinates studies with outside organizations.
• Follows procedure to ensure compliance with Design Control Procedures.
• Complies with client's procedures and directives, FDA and ISO requirements.
• Responsible for Design Control and Design History File documentation.
• Writes validations as needed.
• Responsible for participating in FDA and client's required training as outlined in the Personnel Training Procedure in a timely and proactive manner.
• Responsible for additional tasks/duties as required or requested by supervisor.

The above description outlines the most common job duties; however, it does not exclude other
potential work assignments.

Education or Formal Training Required:

• 4-year degree in Chemical or Biomedical Engineering
• Masters degree desirable

Qualifications Required: (knowledge, skills, abilities, initiative, judgment, etc.)

• Three or more years experience in medical device product development & design control
• Experience with resorbable biomaterials
• Experience with bone graft materials a plus
• Solid problem-solving skills
• Solid analytical knowledge of biomaterials
• Strong decision-making skills
• Excellent communication skills – both written and oral
• Strong multi-tasking ability
• Ability to work as a team player – proven ability to interact with manufacturing, marketing & quality departments
• Ability to follow written guidelines
• Ability to write and interpret specific protocols
• Mathematical ability
• Ability to work independently, plan and prioritize
• Ability to be flexible/adapt as daily schedule may change rapidly.
• Computer proficiency

Extent of Supervision:
Minimal supervision. A wide degree of latitude is expected. Relies on experience and judgment to
plan and accomplish goals. Reports to the Director of Research & Development.

Work Conditions / Physical Demands:
The physical demands described here are representative of those that must be met by an employee to successfully preform the essential functions of the job. Reasonable accommodations may be made when requested by the employee to enable individuals with disabilities to perform the essential functions.

• This position requires the incumbent to regularly utilize written and verbal communication skills, including active listening and speaking clearly and concisely.
• This position requires the incumbent to experience periods of prolonged sitting and to occasionally stand, walk, carry items, climb, reach, and lift up to 20 lbs.
• This position requires the incumbent to operate office equipment such as telephones, computers, fax machines, copiers, and to grasp objects utilizing manual dexterity including hand/finger coordination.
• Light manufacturing, and laboratory operations
• Clean room/controlled environment operations
• Potential exposure to dust, noise, and odor, Potential exposure to various chemicals

Travel requirements: Minimum travel, less than 10%

Benefits/Compensation (including but not limited to):
Medical and dental insurance, group life insurance, 401k matching, long term disability, potential target bonus, paid time off.

Salary Range: $80K - $100K, based on education and experience

Environment: This work environment is fantastic! The facility is awesome, and work from home is allowed and respected in an integrated part of the culture.