Senior Manufacturing Engineer - Medical Device
We are an innovative and quality driven medical device company! Our specialization is in the development, manufacturing, and sales of surgical devices and solutions.
We are ISO 13485 Certified and FDA Registered. And we have respectful working environment!
Location: Nashua, NH and work onsite. Base Salary, is DOE
Job Overview:
Lead development and maintenance of comprehensive product roadmaps, incorporating design updates, process improvements, and product demonstrations based on clinical feedback.
Facilitate Joint Application Development (JAD) sessions with stakeholders, end users, and physicians to guide product enhancements.
Guide Class II medical devices through FDA 510(k) clearance by coordinating clinical trials and analyzing performance data.
Identify and resolve workflow bottlenecks through implementation and standardization of process flows.
Engineer custom tool fixtures to address manufacturing inconsistencies in the medical device production line's solvent mixture.
Enhance workplace safety through development of new standard operating procedures and comprehensive risk assessments across all production processes.
Improve first-pass yields by identification of quality control gaps and implementation of new measurement systems and inspection procedures.
Partner with cross-functional teams to develop and optimize device testing protocols and documentation, ensuring robust quality assurance.
Ability to write test protocols, ECOs, corrective actions, and process deviations in clear and concise language using good organizational skills.
Learn relevant technical aspects of our devices and their construction to serve a supporting role on the production floor.
Communicate effectively with both peers and production floor personnel, many of whom are not fluent in English (may need to work through translators).
Be prepared to wear many hats, resolve conflicting ideas, and direction from outside manufacturing.
Ensure compliance with regulatory standards and requirements.
Provide technical support on the production floor.
Required Qualifications:
May I please request all interested, serious and suitable candidates to please complete the short application questions ASAP! Complete applications will certainly speed up the interview process!
We'd like to get you set up for an interview ASAP if you like this opportunity and are suitable.
If the application questions are completed it will speed up your candidacy and will be sending your answers to the hiring authority after our talk and your permission!
1. Apply directly to this job opening here!
And/Or 2. E-mail directly for more information to Lynne.azkoul-polanis@cybercoders.com
Setting up interviews now!
Benefits
We are an innovative and quality driven medical device company! Our specialization is in the development, manufacturing, and sales of surgical devices and solutions.
We are ISO 13485 Certified and FDA Registered.
Location: Nashua, NH
Onsite position and may consider some hybrid working arrangement
Base Salary, DOE
Job Overview:
Lead development and maintenance of comprehensive product roadmaps, incorporating design updates, process improvements, and product demonstrations based on clinical feedback.
Facilitate Joint Application Development (JAD) sessions with stakeholders, end users, and physicians to guide product enhancements.
Guide Class II medical devices through FDA 510(k) clearance by coordinating clinical trials and analyzing performance data.
Identify and resolve workflow bottlenecks through implementation and standardization of process flows.
Engineer custom tool fixtures to address manufacturing inconsistencies in the medical device production line's solvent mixture.
Enhance workplace safety through development of new standard operating procedures and comprehensive risk assessments across all production processes.
Improve first-pass yields by identification of quality control gaps and implementation of new measurement systems and inspection procedures.
Partner with cross-functional teams to develop and optimize device testing protocols and documentation, ensuring robust quality assurance.
Our best candidates have the following experience with at least 4+++ years:
Solid understanding of FDA, IEC, MDSAP, and other ROW medical device standards and requirements.
Ability to write test protocols, ECOs, corrective actions, and process deviations in clear and concise language using good organizational skills.
Learn relevant technical aspects of our devices and their construction to serve a supporting role on the production floor.
Communicate effectively with both peers and production floor personnel, many of whom are not fluent in English (may need to work through translators).
Be prepared to wear many hats, resolve conflicting ideas, and direction from outside manufacturing.
Ensure compliance with regulatory standards and requirements.
Provide technical support on the production floor.
Write and maintain clear and concise documentation.
Required Qualifications:
Medical device industry experience with at least 4+ years.
Strong knowledge of FDA, IEC, MDSAP, and other ROW medical device standards and requirements.
Excellent organizational skills and ability to write clear and concise test protocols, ECOs, corrective actions, and process deviations.
Technical aptitude to learn and understand the construction and functionality of our devices.
Effective communication skills, especially in a multilingual environment.
Flexibility and problem-solving skills to manage multiple roles and resolve conflicting ideas.
Bachelor's degree.
Preferred Qualifications:
Must have:
-Experience in the medical device industry.
-Familiarity with ISO 13485 standards.
-Previous experience working in a production environment.
May I please request all interested, serious and suitable candidates to please complete the short application questions ASAP! Complete applications will certainly speed up the interview process! We'd like to get you set up for an interview ASAP if you'd like this opportunity and are suitable.
If the application questions are completed it will speed up your candidacy and will be sending your answers to the hiring authority after our talk and your permission!
1. Apply directly to this job opening here!
And/Or
2. E-mail directly for more information to Lynne.azkoul-polanis@cybercoders.com
Setting up interviews now!
For this position you must be currently authorized to work in the United States. We do not sponsor for this position.
Lynne Azkoul-Polanis is recruiting for this position and the positions below.
Email me to apply for this position
