Career
Senior Product Development Engineer
Responsibilities
- Support Product Development activities across products, applications, and functional areas, with emphasis on the microfluidic based sterile single use consumables which interface to the instrumentation platform.
- Engage in all phases of product development from concept through commercialization and post market support.
- Directly contribute to product and component requirements specifications, design/selection, verification, and validation activities, including plan development and execution, working with program management and systems engineering to establish project deliverables and schedules.
- Collaborate with internal, and external development and manufacturing partners, technical staff, and outside test laboratories to ensure timely and high quality product development activity execution.
- Participate in the preparation for and execution of Technical and Phase-Gate Design Reviews.
- Propose and implement design and manufacturing changes to meet product quality and cost objectives.
- Communicate technical issues and risks to the team and propose solutions and mitigation strategies.
- Provide input to the Design History File documents, including Requirements Specifications and Product Risk and Hazard Analyses.
- Develop and manage product specifications and transfer to contract manufacturers.
- Prepare and/or review engineering specification documentation, Document Change Orders, Bills of Materials, and associated design and manufacturing documentation.
- Support process development, documentation, and characterization.
- Actively participate in regular project meetings, including technical design reviews.
- Support and/or provide content for IP and regulatory filings
- Support Quality and Operations related to supplier selection, qualification, and transfer of designs to manufacturing.
- Travel up to approximately 10%, including internationally.
Experience and Qualifications
- BS or MS degree in a relevant engineering discipline, Mechanical or Plastics Engineering preferred.
- At least 10 years experience, 5 years of medical device development experience, including single use consumables.
- Strong working knowledge of DFX methodologies and techniques.
- Cross-functional team participation in at least one project through to commercial stage.
- Working understanding of FDA, GMP, and ISO regulations required.
- Experience with design of injection molded plastic parts and associated tooling – microfluidic scale device design experience a significant plus.
- Proficiency with SolidWorks.
- Experience planning and executing equipment process validation and statistical process control.
- Excellent organization, problem solving, and written and verbal communication skills.
- Ability to work effectively with cross-functional teams and communicate with multiple levels in the organization.
- Initiative in leveraging and engaging others in accomplishing objectives.
To request additional information or submit your resume, contact us at email: info at auroraprosci dot com.
Document Control Specialist
Responsibilities
- Administration and life cycle management of procedural documents including policies, standard operating
- procedures, work instructions, records and forms.
- Be responsible for the following daily documentation related activities: creation/edit, review, approval,
- effectuation, obsolescence, archival and distribution.
- Provide expertise to document originators, ensuring documents are created/edited per current procedures (i.e. correct template, format, content, references, document properties, types of approvers).
- Ensure proper access of all employees to procedural documents.
- Monitor, reconcile and audit approved documents, ensuring all compliance requirements for format, content, standardization and periodic review.
- Ensure document implementation schedules are met to ensure product quality and customer expectations are met.
- Ensure that training/education programs and course materials are current and accurate, and document effective date does not result in adverse impact to trainees or training metrics.
- Provide oversight/support of periodic document review process.
- Assist with reporting and analysis of Document Review metrics for Management Review.
- Serve as the BoxTM document control system super user and train new associates or document owners in document management processes and the use of BoxTM.
Experience and Qualifications
- One of the following is required:
- Bachelor’s degree plus 2 years of relevant experience.
- Associate’s degree plus 4 years of relevant experience.
- 4 year High School diploma plus years of relevant experience.
- A minimum of 2 years’ experience in document management.
- Prior use of an electronic document management system is required.
- Experience with conversion from paper to electronic based 21 CFR Part 11 compliant system a plus.
- Knowledge of FDA regulations, 21 CFR Part 11 requirements, cGMP related to documentation and ISO 13485 standards required.
- Prior experience delivering training to colleagues and partners is preferred.
- Experience providing support for internal audits and inspections by regulatory authorities a plus.
- Familiar with BoxTM a plus.
- Sharp attention to detail.
- Good time management skills.
- Proficient organizational skills.
- Excellent written and oral communication skills.
- Written and spoken communication of the English language is required.
To request additional information or submit your resume, contact us at email: info at auroraprosci dot com.
Product Account Manager
We are seeking a highly motivated individual to join our team as a sales representative for lab equipment and devices. In this role, you will be responsible for managing a sales territory and identifying potential customers within the scientific community.
Responsibilities:
- Developing and implementing a sales strategy to achieve revenue targets
- Building relationships with potential customers, including researchers and lab managers
- Presenting and demonstrating the features and benefits of our lab equipment and devices to potential customers
- Negotiating contracts and closing sales
- Providing ongoing support to customers to ensure their satisfaction
To be successful in this role, you should have a strong understanding of the scientific community and its needs, as well as excellent communication and interpersonal skills. Previous experience in sales, particularly within the scientific industry, is highly desirable.
If you are self-motivated, detail-oriented, and have a passion for sales, we would love to hear from you. This is a full-time position with competitive compensation and benefits.
To request additional information or submit your resume, contact us at email: info at auroraprosci dot com.